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Business, Entrepreneurialism, and Management

Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Salary Breakdown

Regulatory Affairs Managers

Average

$121,290

ANNUAL

$58.31

HOURLY

Entry Level

$60,710

ANNUAL

$29.19

HOURLY

Mid Level

$111,740

ANNUAL

$53.72

HOURLY

Expert Level

$169,250

ANNUAL

$81.37

HOURLY


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Regulatory Affairs Managers

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Estrella Mountain Community College
  Avondale, AZ 85392      Degree Program

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  Phoenix, AZ 85034      Degree Program

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  Phoenix, AZ 85013-4234      Degree Program

Paradise Valley Community College
  Phoenix, AZ 85032-1200      Degree Program

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  Tempe, AZ 85281-6950      Degree Program

Scottsdale Community College
  Scottsdale, AZ 85256-2626      Degree Program

South Mountain Community College
  Phoenix, AZ 85040      Degree Program

Mesa Community College
  Mesa, AZ 85202-4866      Degree Program

Chandler-Gilbert Community College
  Chandler, AZ 85225-2479      Degree Program

Scottsdale Community College
  Scottsdale, AZ 85256-2626      Degree Program

Chandler-Gilbert Community College
  Chandler, AZ 85225-2479      Degree Program

Glendale Community College
  Glendale, AZ 85302      Degree Program

GateWay Community College
  Phoenix, AZ 85034      Degree Program

Phoenix College
  Phoenix, AZ 85013-4234      Degree Program

Paradise Valley Community College
  Phoenix, AZ 85032-1200      Degree Program

Rio Salado College
  Tempe, AZ 85281-6950      Degree Program

Scottsdale Community College
  Scottsdale, AZ 85256-2626      Degree Program

South Mountain Community College
  Phoenix, AZ 85040      Degree Program

Mesa Community College
  Mesa, AZ 85202-4866      Degree Program

Estrella Mountain Community College
  Avondale, AZ 85392      Degree Program

Current Available & Projected Jobs

Regulatory Affairs Managers

14

Current Available Jobs

27,820

Projected job openings through 2032


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Regulatory Affairs Managers


Knowledge, Skills & Abilities

Regulatory Affairs Managers

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

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SKILL

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ABILITY

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Oral Comprehension

ABILITY

Oral Expression

ABILITY

Written Comprehension

ABILITY

Deductive Reasoning


Job Opportunities

Regulatory Affairs Managers

  • Risk & Compliance Director (Remote EST Preferred)
    CBRE    Phoenix, AZ 85067
     Posted 3 days    

    Risk & Compliance Director (Remote EST Preferred)

    Job ID

    218394

    Posted

    27-May-2025

    Service line

    GWS Segment

    Role type

    Full-time

    Areas of Interest

    Risk Management

    Location(s)

    Remote - US - Remote - US - United States of America

    **About the Role:**

    As a CBRE Compliance Director, you will direct and provide overall strategic management of the compliance team for a department or line of business.

    This job is part of the Legal Compliance job function. They are responsible for overseeing regulatory compliance that balances business and compliance solutions to inform the company of options and risks.

    **What You’ll Do:**

    + Provide formal supervision to employees. Monitor the training and development of staff. Conduct performance evaluations and coaching. Oversee the recruiting and hiring of new employees.

    + Coordinate and manage the team's daily activities. Establish work schedules, assign tasks, and cross-train staff. Set and track staff and department deadlines. Mentor and coach as needed.

    + Establish strategic objectives and goals. Champion and drive change while ensuring quality while mitigating risk to our clients and company.

    + Oversee employee and supplier employee onboarding compliance specifically in relation to client background screening requirements.

    + Work with executive management to identify and prioritize rollouts of a risk assessment and business continuity program

    + Coordinate and conduct high-level and/or escalated investigations. Explain and defend findings. Draft investigation reports and provide recommendations and corrective action to management.

    + Interpret, develop, and execute functional policies, procedures, and processes. Ensure systems and processes are compliant with regulations globally, account MSA, and client requirements.

    + Council the business on the assessment process and educate on exposure.

    + Review and approve updates to the departmental policies & procedures manual and associated forms.

    + Direct program assessment and audit efforts. Approve audit templates and review calendar, progress, and provide additional resources as needed.

    + Serve as subject matter expert and participate in compliance consulting engagements upon request. Prepare and deliver presentations to all levels of management.

    + Apply a robust knowledge of multiple disciplines, the business, and key drivers which impact departmental and cross-functional performance.

    + Lead by example and model behaviors that are consistent with CBRE RISE values. Persuade managers and other colleagues to take action while being guided by the organization's functional business plans. Negotiate with external partners, vendors, and customers of divergent interests to reach a common goal.

    + Identify and solve multi-dimensional, complex, operational, and organizational problems leveraging the appropriate resources within or outside the department.

    + Significantly improves and changes existing methods, processes, and standards within job discipline.

    **What You’ll Need:**

    + Bachelor's Degree preferred with 8-12 years of relevant experience. In lieu of a degree, a combination of experience and education will be considered.

    + Experience in the areas of staffing, selection, training, development, coaching, mentoring, measuring,

    + Appraising and rewarding performance and retention is preferred.

    + Ability to lead the exchange of sensitive, complicated, and difficult information, convey performance expectations, and handle problems.

    + Leadership skills to set, manage and achieve targets with a direct impact on multiple departments' results within a function.

    + In-depth knowledge of Microsoft Office products. Examples include Word, Excel, Outlook, etc.

    + Expert organizational skills and an advanced inquisitive mindset.

    + Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.

    CBRE carefully considers multiple factors to determine compensation, including a candidate’s education, training, and experience. The minimum salary for the position is $135,000 annually and the maximum salary for the position is $160,000 annually. The compensation that is offered to a successful candidate will depend on the candidate’s skills, qualifications, and experience. Successful candidates will also be eligible for a discretionary bonus based on CBRE’s applicable benefit program.

    The application window is anticipated to close on June 3, 2025 and may be extended as needed. Or to express interest in similar roles, visit CBRE.com/careers.

    **Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.

    **Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company’s success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at recruitingaccommodations@cbre.com or via telephone at +1 866 225 3099 (U.S.) and +1 866 388 4346 (Canada).

    CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)


    Employment Type

    Full Time

  • RWD Compliance Manager
    Norstella    Phoenix, AZ 85067
     Posted 7 days    

    RWD Compliance Manager

    Company: Norstella

    Location: Remote, United States

    Date Posted: May 23, 2025

    Employment Type: Full Time

    Job ID: R-1204

    **Description**

    **About Norstella:**

    At Norstella, our mission is simple: to help our clients bring life-saving therapies to market quicker—and help patients in need. Founded in 2022, but with history going back to 1939, Norstella unites best-in-class brands to help clients navigate the complexities at each step of the drug development life cycle —and get the right treatments to the right patients at the right time.

    Each organization (Citeline, Evaluate, MMIT, Panalgo, The Dedham Group) delivers must-have answers for critical strategic and commercial decision-making. Together, via our market-leading brands, we help our clients:

    • Citeline – accelerate the drug development cycle

    • Evaluate – bring the right drugs to market

    • MMIT – identify barrier to patient access

    • Panalgo – turn data into insight faster

    • The Dedham Group – think strategically for specialty therapeutics

    By combining the efforts of each organization under Norstella, we can offer an even wider breadth of expertise, cutting-edge data solutions and expert advisory services alongside advanced technologies such as real-world data, machine learning and predictive analytics. As one of the largest global pharma intelligence solution providers, Norstella has a footprint across the globe with teams of experts delivering world class solutions in the USA, UK, The Netherlands, Japan, China and India.

    **The Role:**

    We are seeking a highly motivated and detail-oriented Real World Data Compliance Manager to join our team. The successful candidate will be responsible for ensuring the highest levels of compliance across our real world data products. This role involves understanding and applying contractual and legal obligations to our deliverables, pitch decks, and customer materials.

    **Responsibilities:**

    • Contractual Compliance: Ensure that all sales of RWD adhere to contractual requirements, including approved use cases, combinations of data sets, and customer approvals

    • Review and Approval: Conduct thorough reviews of pitch decks and other customer-facing materials to identify and address compliance issues at an early stage

    • TPA request assessment: Ensure Third-Party Agreement (TPA) requests involving RWD are compliant with data vendor flow-down terms

    • Documentation and Reporting: Maintain accurate records of compliance assessments and provide regular reports to senior management on compliance status and any identified risks

    • Training and Guidance: Provide training and guidance to sales and marketing teams on compliance requirements and best practices for handling RWD

    • Collaboration: Work closely with the legal, privacy, and data governance teams to ensure alignment on compliance policies and procedures

    • Risk Management: Identify potential compliance risks and develop strategies to mitigate them

    • Auditing: provide support as needed when RWD vendors audit our systems and commercial activity for compliance with contractual terms

    • Continuous Improvement: Stay updated on industry regulations and best practices related to RWD compliance and implement improvements to internal processes as needed

    **Qualifications:**

    • Education: Bachelor's degree in Law, Business Administration, Data Science, or a related field.

    • Experience: Minimum of 5 years of experience in compliance management, preferably within the healthcare or data industry.

    • Knowledge: Strong understanding of contractual obligations, data privacy laws (e.g., HIPAA), and industry standards for RWD

    • Skills: Excellent analytical, organizational, and communication skills. Ability to work independently and collaboratively in a fast-paced environment.

    • Certifications: Compliance certifications (e.g., CCEP, CHC) are a plus.

    **Our Guiding Principles for success at Norstella:**

    01: Bold, Passionate, and Mission-First

    02: Integrity, Truth, and Reality

    03: Kindness, Empathy, and Grace

    04: Resilience, Mettle, and Perseverance

    05: Humility, Gratitude, and Learning

    **Benefits:**

    • Medical and Prescription Drug Benefits

    • Health Savings Accounts (HSA) or Flexible Spending Accounts (FSA)

    • Dental & Vision Benefits

    • Basic Life and AD&D Benefits

    • 401k Retirement Plan with Company Match

    • Company Paid Short & Long-Term Disability

    • Paid Parental Leave

    • Paid Time Off & Company Holidays

    _The expected base salary for this position ranges from $175,000 to $200,000. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, licensure or certifications obtained. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible to receive a discretionary bonus._

    _Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law._

    _Sometimes the best opportunities are hidden by self-doubt. We disqualify ourselves before we have the opportunity to be considered. Regardless of where you came from, how you identify, or the path that led you here- you are welcome. If you read this job description and feel passion and excitement, we’re just as excited about you._

    _All legitimate roles with Norstella will be posted on Norstella’s job board which is located at norstella.com/careers. If a role is not posted on this job board, a candidate should assume the role is not a legitimate role with Norstella. Norstella is not responsible for an application that may be submitted by or through a third-party and candidates should proceed with extreme caution if a third-party approaches them about an open role with Norstella. Norstella will never ask for anything of value or any type of payment during or as part of any recruitment, interview, or pre-hire onboarding process. If you are aware of or have reason to believe a job posting purportedly for a role with Norstella is fraudulent or otherwise not authorized by Norstella, please contact the Company using the following email address:_ __ _._

    Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law.


    Employment Type

    Full Time

  • Senior Corporate Compliance Manager - Training, Communications & Policy (Remote)
    United Therapeutics    Phoenix, AZ 85067
     Posted 8 days    

    California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

    **The job details are as follows:**

    Who we are

    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

    United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

    The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

    Who you are

    You are a strategic thinker with a passion for integrity and educating others. You are a natural communicator who can translate complex requirements into clear, engaging, and actionable learning experiences. Detail-oriented yet creative, you balance policy management with innovative training strategies that resonate across all levels of the organization. You thrive in a dynamic environment, proactively identifying risks and opportunities to enhance compliance awareness. As a leader, you like to mentor and can partner effectively with fellow compliance teammates, in addition to other stakeholders and vendors. With a strong mix of analytical skills, instructional design expertise, and a commitment to ethical business practices, you drive a culture of compliance with confidence and enthusiasm.

    The Senior Corporate Compliance Manager – Training, Communications and Policy will be responsible for:

    + OVERSIGHT & RESPONSIBILITY:

    + Lead the strategy, development and execution of the Compliance Department’s training, policy and communications initiatives

    + Promote a proactive approach to Compliance that is focused on partnerships, prevention, and education

    + Assist with development of reporting to Compliance Committee and to the Board of Directors

    + POLICIES & PROCEDURES:

    + Drive compliance through the development, review/update and implementation of principles-based Compliance policies and procedures in partnership with Compliance Business Partners, Legal and stakeholders

    + Lead the creation of policy and procedure-based resources

    + Develop annual strategy around policy development and revision based on business and compliance priorities in partnership with Compliance Business Partners

    + TRAINING & COMMUNICATION:

    + Establish and maintain dialogue with Compliance business partners and stakeholders to understand the Company’s training needs

    + Develop annual training and communication strategy in collaboration with Compliance Business Partners and stakeholders

    + Create and/or facilitate creation of engaging, role-specific Compliance trainings and communications

    + Deliver engaging training with the ability to adapt and deliver both virtually and in-person * Effectively communicate compliance program developments to stakeholders

    + OTHER:

    + Raise awareness of the Compliance program and foster department and organization-wide accountability for compliance

    + Maintain effective rapport with team members, consultants and stakeholders

    + Manage Corporate Compliance Operations Specialist II, who is responsible for administration of compliance training and communication

    Minimum Requirements

    + 10+ years of experience in compliance in the life sciences industry: pharmaceutical, medical or biotech with a Bachelor's Degree or

    + 8+ years of experience in compliance in the life sciences industry: pharmaceutical, medical or biotech with a Master's Degree

    + 4+ years of experience related to creation and delivery of compliance training

    + 3+ years of experience related to managing a direct report

    + Ability to build and maintain professional relationships with internal stakeholders

    + Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet the company's needs

    + Demonstrated knowledge of regulatory/compliance requirements, including Anti-Kickback Statute, False Claims Act, government pricing regulations, and state price transparency laws and regulations

    + Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner

    + Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization

    + Strong analytical and problem-solving skills

    + Strong attention to detail and accuracy

    + Strong collaborative, interpersonal and oral communication skills

    + Excellent written communication skills, including robust and advanced documentation practices

    + Handles confidential matters with discretion and solid judgement

    + Produces high quality work with minimal oversight from manager

    + Ability to travel up to 25% (which can include one week onsite in our RTP office monthly).

    Preferred Qualifications

    + Master’s Degree in business, finance, life sciences or another healthcare-related field

    Job Location

    This position can be located remotely within the United States.

    The salary for this position ranges from $138,000 to $175,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.

    The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

    At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

    Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

    United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

    _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._

    _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._


    Employment Type

    Full Time

  • Regulatory Compliance Manager
    Cardinal Health    Phoenix, AZ 85067
     Posted 8 days    

    **_What Regulatory Compliance contributes to Cardinal Health_**

    Regulatory Compliance develops and implements strategies and standard operating procedures to promote the company’s adherence to relevant laws, regulations, and internal policies, including monitoring for compliance and development and implementation of comprehensive compliance programs impacting GMPD products.

    **_Job Summary_**

    In line with Cardinal Health business objectives, the Regulatory Compliance Manager will assist with managing Global regulatory compliance across Global Medical Products and Distribution (GMPD) that includes identification and monitoring of relevant standards and regulations pertaining to Cardinal Health products and services in key markets globally, and development comprehensive regulatory compliance execution strategies. The selected candidate will play an essential role in fostering trusted engagement with external regulators, industry associations, patient advocacy groups, and internal Cardinal Health stakeholders to develop, influence and lead the development of internal and external regulatory policies.

    Leverage broad knowledge of regulatory affairs, quality management systems and business operations to develop regulatory strategies utilizing the least burdensome execution approaches, making risk-based decisions while achieving regulatory compliance and business goals, maintaining compliance integrity across the GMPD and prioritizing workload to best achieve desired end state.

    **_This is a 100% remote position but will require regular travel to Mansfield, MA, Waukegan, IL, Dublin, OH and Hazelwood, MO. The ideal candidate would be located close to one of these facilities._**

    **Responsibilities**

    + Identify, monitor, and interpret global healthcare and environmental regulations impacting GMPD products and product-related processes for efficient, cost-effective and compliant support of global operations, including import and export, through clear & consistent assessment of regulatory requirements and development of streamlined compliance execution strategies while helping to mitigate regulatory, legal and financial risks for the business and ensure business continuity of Cardinal Health products and services.

    + Develop and maintain comprehensive and timely compliance programs and internal policies and procedures and that align with regulatory requirements throughout the product lifecycle, from design and development to end of life activities.

    + Represent Cardinal Health in interactions with relevant regulatory authorities and 3rd party vendors on matters related to regulatory strategies and global compliance execution and act as a point of contact for regulatory agencies.

    + Respond to inquiries and requests, both internal and external.

    + Develop and deliver training programs for employees to ensure awareness and understanding of relevant regulations.

    + Prepare and present compliance reports to senior management (including, but not limited VP, SVP, GM/CEO level), highlighting key risks and proposed mitigation solutions.

    + Manage and maintain accurate and complete regulatory documentation of compliance activities.

    + Identify and resolve compliance issues, develop and implement corrective actions and identify opportunities for improvement in compliance programs and processes.

    **Qualifications**

    + Bachelor's degree in scientific or compliance field, e.g., Legal, Regulatory Affairs, Engineering discipline, or equivalent work experience, preferred

    + Regulatory Affairs experience in Medical Device industry

    + Minimum of 5 years of relevant experience

    + Proficiency in global medical devices, environmental and sustainability regulations

    + Strong organizational skills

    + Ability to multitask and manage multiple projects

    + Negotiation skills

    + Deadline conscious

    + Problem solving skills

    + Critical thinking

    + Strong oral and written communication skills

    + Ability to travel up to 25%

    **_What is expected of you and others at this level_**

    + Stay current with and maintain a good understanding of evolving global regulatory requirements.

    + Apply advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects

    + Participate in the development of policies and procedures to achieve specific goals

    + Recommend new practices, processes, metrics, or models

    + Work on and lead complex projects of large scope

    + Projects may have significant and long-term impact

    + Provide solutions which may set precedent

    + Independently determine method for completion of new projects

    + Receive guidance on overall project objectives

    + Act as a mentor to less experienced colleagues

    **Anticipated salary range** : $103,500 - $147,900

    **Bonus eligible** : Yes

    **Benefits** : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

    + Medical, dental and vision coverage

    + Paid time off plan

    + Health savings account (HSA)

    + 401k savings plan

    + Access to wages before pay day with myFlexPay

    + Flexible spending accounts (FSAs)

    + Short- and long-term disability coverage

    + Work-Life resources

    + Paid parental leave

    + Healthy lifestyle programs

    Application window anticipated to close: 6/20/2025 *if interested in opportunity, please submit application as soon as possible.

    The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

    \#LI-MP1

    \#LI-remote

    _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._

    _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._

    _To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)


    Employment Type

    Full Time

  • Hybrid Trade Compliance Manager 7+ Years
    Robert Half Legal    Phoenix, AZ 85067
     Posted 19 days    

    Description

    We are looking for an experienced Trade Compliance Manager with extensive export experience to oversee and enhance compliance efforts across our public company client's U.S. West Coast facilities. This role involves developing and enforcing policies related to international trade regulations, ensuring adherence to global trade laws, and collaborating with cross-functional teams to achieve compliance objectives. Based in Phoenix, Arizona, (or San Diego, CA), this position offers a hybrid work schedule (3 days a week in-office required), 30% travel, and reports directly to the Chief Legal Officer.

    Responsibilities:

    • Lead the development and implementation of a comprehensive global trade compliance program, providing guidance to teams on company policies and regulatory requirements.

    • Advise on compliance with regulations from the Department of State, Department of Commerce, and other relevant agencies, including export licensing and the Foreign Corrupt Practices Act.

    • Conduct trade compliance audits and investigations, ensuring corrective actions are implemented effectively.

    • Design tools and performance metrics to monitor the effectiveness of export and import controls as well as supply chain security programs.

    • Evaluate export license requirements and manage licensing activities in accordance with U.S. and international trade laws.

    • Deliver tailored training programs on export controls and compliance for internal and external stakeholders through webinars and in-person sessions.

    • Oversee the use of compliance systems, providing training and support for export and import reporting while conducting periodic audits.

    • Collaborate with Human Resources to manage deemed export compliance and ensure regulatory adherence.

    • Identify and implement compliance best practices across facilities to promote standardization and cost efficiency.

    • Maintain and administer compliance software systems, ensuring accurate reporting and adherence to import/export requirements.

    Requirements

    • Minimum of 7+ years of experience in trade compliance or a related field.

    • Proficiency in compliance software and tools, including CRM and EHR systems.

    • Strong understanding of U.S. and international trade regulations, including export controls and customs requirements.

    • Experience conducting audits and investigations with a focus on corrective actions.

    • Excellent communication skills with the ability to deliver training and compliance education programs.

    • Familiarity with customs brokerage and supply chain security compliance.

    • Proven ability to manage complex licensing processes and maintain accurate reporting systems.

    • Strong organizational skills with attention to detail and the ability to manage multiple priorities and travel as necessary.

    Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

    Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.

    All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

    © 2025 Robert Half. Robert Half is not a law firm and does not provide legal representation. Robert Half project lawyers do not constitute a law firm among themselves. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .


    Employment Type

    Full Time

  • Compliance Manager
    Fujifilm    Phoenix, AZ 85067
     Posted 19 days    

    **Position Overview**

    We are hiring a Compliance Manager to be a member of the FUJIFILM Holdings America Corporation Compliance Department. The Compliance Manager will conduct day-to-day management of compliance activities for FUJIFILM North America Corporation to ensure ongoing corporate compliance with internal and external standards.

    Our ideal candidate would reside in the Eastern US.

    **Company Overview**

    FUJIFILM Holdings America Corporation is the regional headquarters for the Americas. It is comprised of 27 affiliate companies across North and Latin America that are engaged in the research, development, manufacture, sale and service of Fujifilm products and services. The company’s portfolio represents a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography. For more information, please visit: https://www.fujifilm.com/us/en/about/region .

    FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com .

    For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030,click here (https://holdings.fujifilm.com/en/sustainability/plan/svp2030) .

    **Job Description**

    **Responsibilities**

    + Manage FNAC compliance program in line with industry best practices and regulations.

    + Collaborate with FNAC Divisions’ Compliance Officers to implement and execute all HLUS Compliance initiatives.

    + Conduct compliance policy and procedure assessment, and support/develop new or updated polices, procedure or systems to address new risk areas or to improve operations and/or internal controls.

    + Conduct compliance risk analyses, identifying potential areas of vulnerability and risk, develop and implement action plans to mitigate potential risks, and follow up on status and effectiveness.

    + Assist in identifying compliance training needs, develop and deliver training to employees to ensure awareness, understanding, and compliance with policies and all rules and regulations. Provide in-person training when required.

    + Actively support internal auditing and monitoring activities for policy compliance. Track corrective and preventive action plans associated with previous audit findings and manage internal and external corrective action plans.

    + Keep abreast of new legislation and enforcement matters affecting global FNAC operations, as well as industry and compliance best practices.

    + Promote reporting of compliance concerns (including use of the compliance reporting systems when appropriate) and generally serve as the FNAC advocate for the establishment of a culture of compliance and sound ethical behavior.

    + Conduct and oversee misconduct investigations and synthesizing fact patterns, developing and executing testing procedures, reviewing data for patterns and anomalies, conducting electronic reviews of information, developing questions for, conducting, and summarizing interviews with identified parties.

    + Develop reports and other materials for FNAC and HLUS management on incidents, emerging compliance challenges, general compliance activities, and communicate the results of investigations, including control deficiencies or weaknesses, fraud matters, root causes, and recommendations, to various stakeholders and audiences.

    + Ensure third-party intermediaries are subject to proper due diligence and comply with the Anti-Corruption and Due Diligence Procedure. Oversee annual compliance certifications.

    + Assist with pre-acquisition due diligence of new businesses and help develop integration plan in relation to matters of corporate compliance.

    + Develop internal communication and compliance campaigns to raise awareness to relevant topics.

    + May travel to support face-to-face meetings.

    + Any other duties commensurate with the role.

    **Required Skills/Education**

    + Bachelor’s degree

    + 5+ years of experience in corporate compliance role.

    + Experience in conducting audits and investigations.

    + Possess the interpersonal skills required to deal with multifunctional project teams and stakeholders.

    + Ability to influence and communicate effectively (written and verbal) at all levels.

    + Working knowledge of Word, Excel, and PowerPoint.

    **Desired Skills**

    + Juris Doctor

    + Strong project management skills, to include managing and prioritizing multiple concurrent projects, and reporting progress and risks to colleagues and senior management.

    + Demonstrated ability to advise and collaborate with management on compliance issues, facilitating risk assessment, and developing practical business solutions.

    + Ability to establish and maintain objectivity while providing superior customer service.

    + Collaborative skills, as well as the ability to excel in a dynamic, fast-paced environment.

    + Ongoing demonstration of strong work ethic, tenacity, and attention to detail, with appreciation for the big picture.

    + Fluency in Spanish is a plus.

    **Salary and Benefits:**

    + $140,000 - $150,000 depending on experience

    + Medical, Dental, Vision

    + Life Insurance

    + 401k

    + Paid Time Off

    *\#LI-REMOTE

    **EEO Information**

    Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

    **ADA Information**

    If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (hlushrteam@fujifilm.com).

    **Job Locations** _US-Remote_

    **Posted Date** _2 weeks ago_ _(4/25/2025 3:17 PM)_

    **_Requisition ID_** _2025-34192_

    **_Category_** _Legal_

    **_Company (Portal Searching)_** _FUJIFILM Holdings America Corporation_


    Employment Type

    Full Time

  • Business Compliance Manager (Aetna SIU)
    CVS Health    Phoenix, AZ 85067
     Posted 19 days    

    At CVS Health, we’re building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care.

    As the nation’s leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues – caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all with heart, each and every day.

    **Position Summary**

    As the Manger of Business Compliance of Quality Review, Training, and Program Integrity, you will lead a team responsible for ensuring the quality and integrity of healthcare fraud and abuse investigations. This role involves overseeing the training and development of team members, managing quality review processes, and ensuring compliance with state regulations and contractual requirements.

    _Flexible on location and remote opportunity in many locations._

    **What You Will Do**

    + Lead a team of Quality Reviewers to effectively assess the prevention, investigation, and prosecution of healthcare fraud and abuse, ensuring the recovery of lost funds.

    + Oversee the planning and execution of quality reviews for investigations related to acts of healthcare fraud and abuse by both members and providers.

    + Provide direction and counsel on case handling, facilitating issue resolution and ensuring high-quality investigations.

    + Assist in identifying resources and determining the best course of action in a timely and effective manner.

    + Conduct comprehensive case reviews and provide constructive feedback to team members on the completeness and quality of their investigations.

    + Evaluate team members and provide ongoing performance feedback to support their professional development.

    + Manage the workload of the team to ensure equitable distribution and exposure to a wide range of cases, aligning with current skills and development needs.

    + Assess training needs and collaborate with the SIU Sr. Manager to create development plans for team members.

    + Develop and maintain strong working relationships with federal, state, and local law enforcement agencies to support the investigation and prosecution of healthcare fraud and abuse.

    + Participate in state meetings and ensure compliance with contractual requirements.

    + Coordinate and collaborate with compliance and senior leadership to align on program integrity initiatives.

    + Contribute to the development and delivery of educational awareness and training programs that meet or exceed state mandates.

    + Participate in federal and state audits to ensure adherence to regulations and standards.

    + _This role ensures that all aspects of the RFP lifecycle are effectively coordinated to meet organizational goals and deadlines._

    + _Oversee vendor managing, working closely with both internal and external clients._

    + Managing multiple projects while leading a production team.

    + Flexible on location.

    **Required Qualifications**

    + Minimum of five years of experience managing healthcare fraud, waste, and abuse investigations, Compliance Auditing, Program Integrity, Regulatory Oversight, Production Monitoring.

    + At least four years of people leading experience is required.

    + Documented record of leading a team greater than eight colleagues.

    + Experience collaborating with state and law enforcement partners.

    + Experience in project management, with the ability to manage multiple priorities and projects simultaneously while meeting deadlines.

    + Strong verbal and written communication skills.

    + Ability to interact effectively with diverse groups of people at various levels and provide timely assistance.

    + Proficient in researching information and identifying relevant resources.

    + Candidates must possess comprehensive knowledge and proficiency in Microsoft Word, Excel, Outlook, SharePoint, QuickBase Management and Visio as well as experience with data analysis tools.

    + Strong analytical skills and the ability to effectively utilize these applications to support data-driven decision-making are essential.

    + Ability to travel up to 20% (approximately 6-9 times per year, depending on business needs).

    + Present in large group sessions via videoconference or in person setting as defined by leadership.

    **Preferred Qualifications**

    + Relevant certifications such as Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE), or similar credentials.

    + Proven experience in managing a quality assurance team, including training and development of staff.

    + Knowledge of company policies and procedures.

    + Familiarity with Medicaid and Medicare plans.

    **Education**

    + Bachelor’s degree in Business Administration, Healthcare Administration, Criminal Justice, or a related field or equivalent experience.

    **Anticipated Weekly Hours**

    40

    **Time Type**

    Full time

    **Pay Range**

    The typical pay range for this role is:

    $54,300.00 - $159,120.00

    This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.

    Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.

    **Great benefits for great people**

    We take pride in our comprehensive and competitive mix of pay and benefits – investing in the physical, emotional and financial wellness of our colleagues and their families to help them be the healthiest they can be. In addition to our competitive wages, our great benefits include:

    + **Affordable medical plan options,** a **401(k) plan** (including matching company contributions), and an **employee stock purchase plan** .

    + **No-cost programs for all colleagues** including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.

    + **Benefit solutions that address the different needs and preferences of our colleagues** including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility.

    For more information, visit https://jobs.cvshealth.com/us/en/benefits

    We anticipate the application window for this opening will close on: 06/30/2025

    Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.

    We are an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.


    Employment Type

    Full Time

  • International Regulatory Affairs Manager
    Cardinal Health    Phoenix, AZ 85067
     Posted 19 days    

    **_What Regulatory Affairs contributes to Cardinal Health_**

    Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

    Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

    **_Job Summary_**

    The Manager, Regulatory Affairs directs regulatory affairs activities, so the organization has the permits, licenses, certificates, authorizations, and other approvals it needs to conduct its current and future business activities. The Manager liaises with managers of other functions to understand their business goals and assesses necessary approvals and related processes to enable those goals. This job also maintains relationships with regulatory authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team of Specialists and manages the operations of the Regulatory Affairs department.

    **_Responsibilities_**

    + Leads a team of Regulatory Specialists. Delegates projects and specific work tasks, reviewing the work of others and providing specific direction to less experienced Specialists. Conducts performance evaluations for team members and makes recommendations to the Director regarding talent management and compensation.

    + Directs the preparation of regulatory submissions, annual renewals, and notifications of product changes. In managing a large number of applications, creates comprehensive schedules to track completion of applications, monitors the success and failure of submissions, and reports progress to the Director.

    + Establishes and maintains positive relationships with government agencies and other regulatory authorities. Represents the organization in matters before regulatory, legislative, or industry standards agencies to advance the organization's interests.

    + Liaises with managers of other functions to understand their business goals, such as introducing a new product or service or entering a new market. Identifies pertinent approvals and regulatory considerations and sets timelines for submitting applications.

    + Manages the preparation of the most difficult, complex, or large application processes so they are likely to be successful. Provides guidance to team members in responding to additional questions and requests from regulators in responses to submitted applications.

    + Provides guidance to internal stakeholders regarding regulatory requirements and the collection and maintenance of information relevant to the submissions. Explains Regulatory Affairs implications and impacts of operational and product changes, leveraging insights from Specialists.

    + Updates and creates new standard operating procedures in response to regulatory developments or significant changes in the organization’s products and operations, so that regulatory submissions and renewals can be completed efficiently and with minimal error.

    + Collaborates with legal counsel for the review of legal terms and in the preparation of complex submissions and renewals. Hires and manages relationships with external consultants as necessary to assist with submissions.

    + Provides insights to senior leadership as a subject matter expert regarding regulatory developments and their potential impacts on the organization’s operations, such that leadership can integrate these insights into short- and long-term strategies.

    **_Qualifications_**

    + 8-12 years of experience, preferred

    + Bachelor’s degree in related field, or equivalent work experience, preferred

    **_What is expected of you and others at this level_**

    + Manages department operations and supervises professional employees, front line supervisors and/or business support staff

    + Participates in the development of policies and procedures to achieve specific goals

    + Ensures employees operate within guidelines

    + Decisions have a short term impact on work processes, outcomes and customers

    + Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management

    + Interactions normally involve resolution of issues related to operations and/or projects

    + Gains consensus from various parties involved

    **Anticipated salary range** : $103,500 - $155,295

    **Bonus eligible** : Yes

    **Benefits** : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

    + Medical, dental and vision coverage

    + Paid time off plan

    + Health savings account (HSA)

    + 401k savings plan

    + Access to wages before pay day with myFlexPay

    + Flexible spending accounts (FSAs)

    + Short- and long-term disability coverage

    + Work-Life resources

    + Paid parental leave

    + Healthy lifestyle programs

    Application window anticipated to close: 5/16/2025 *if interested in opportunity, please submit application as soon as possible.

    The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

    \#LI-MP1

    \#LI-remote

    _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._

    _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._

    _To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)


    Employment Type

    Full Time

  • R&D Regulatory Manager
    Grifols Shared Services North America, Inc    Casa Grande, AZ 85193
     Posted 19 days    

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

    **Summary:**

    Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

    **Primary responsibilities:**

    + Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

    + Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

    + Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

    + Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

    + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

    + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

    + Writes documents with complex scientific information for regulatory submissions.

    + May supervise staff

    + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

    **Additional responsibilities:**

    + Represent R&D Compliance in professional and industry organizations.

    **Knowledge, skills, & abilities:**

    Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

    **Requirements:**

    Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

    Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

    Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

    **Occupational Demands:**

    Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

    Third Party Agency and Recruiter Notice:

    Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

    **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

    Learn more about Grifols (https://www.grifols.com/en/what-we-do)

    **Req ID:** 527460

    **Type:** Regular Full-Time

    **Job Category:** Regulatory Affairs


    Employment Type

    Full Time

  • R&D Regulatory Manager
    Grifols Shared Services North America, Inc    Glendale, AZ 85304
     Posted 19 days    

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

    **Summary:**

    Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

    **Primary responsibilities:**

    + Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

    + Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

    + Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

    + Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

    + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

    + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

    + Writes documents with complex scientific information for regulatory submissions.

    + May supervise staff

    + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

    **Additional responsibilities:**

    + Represent R&D Compliance in professional and industry organizations.

    **Knowledge, skills, & abilities:**

    Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

    **Requirements:**

    Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

    Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

    Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

    **Occupational Demands:**

    Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

    Third Party Agency and Recruiter Notice:

    Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

    **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

    Learn more about Grifols (https://www.grifols.com/en/what-we-do)

    **Req ID:** 527460

    **Type:** Regular Full-Time

    **Job Category:** Regulatory Affairs


    Employment Type

    Full Time


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