Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
Amgen
June 27, 2026
Remote friendly (United States)
United States
Corporate Functions
Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
What You Will Do
- Provide strategic direction for product and disease communications and activities by interpreting the current FDA regulatory environment to ensure truthful and non-misleading communication to the health care community, patients, and the public.
- Formulate and communicate the regulatory promotional position for approved and/or pipeline products.
Key Responsibilities
- Serve on promotional review committees by evaluating proposed pieces and supporting evidence.
- Evaluate promotional enforcement activities and assess the changing regulatory environment for impact to Amgen.
- Update the Promotions group on new learnings and key takeaways from courses, congresses, and tradeshows.
- Mentor Senior Associate and Manager-level reviewers.
- Assess promotional programs against regulatory requirements.
- Identify changes required to meet Promotional Regulation.
Basic Qualifications
- Doctorate degree and 2 years of related experience; or Master’s degree and 4 years; or Bachelor’s degree and 6 years; or Associate’s degree and 10 years; or High school diploma/GED and 12 years.
Preferred Qualifications
- Advertising and promotions technical authority; applies promotional regulations in a changing environment.
- Experience with negotiation, persuasion, collaboration, analytical judgment.
- Understands and applies data/information.
- Leadership, strategic focus, collaboration, independence, clinical knowledge, analytical judgment, negotiation/persuasion, coaching/mentoring, project management, problem solving, time management, organization.
Benefits
- Total Rewards Plan (health/welfare plans, financial plans, work/life balance, career development), including retirement/savings plan, medical/dental/vision, life/disability, flexible spending, discretionary annual bonus/incentive plan (as applicable), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number is received or a candidate is selected.
What You Will Do
- Provide strategic direction for product and disease communications and activities by interpreting the current FDA regulatory environment to ensure truthful and non-misleading communication to the health care community, patients, and the public.
- Formulate and communicate the regulatory promotional position for approved and/or pipeline products.
Key Responsibilities
- Serve on promotional review committees by evaluating proposed pieces and supporting evidence.
- Evaluate promotional enforcement activities and assess the changing regulatory environment for impact to Amgen.
- Update the Promotions group on new learnings and key takeaways from courses, congresses, and tradeshows.
- Mentor Senior Associate and Manager-level reviewers.
- Assess promotional programs against regulatory requirements.
- Identify changes required to meet Promotional Regulation.
Basic Qualifications
- Doctorate degree and 2 years of related experience; or Master’s degree and 4 years; or Bachelor’s degree and 6 years; or Associate’s degree and 10 years; or High school diploma/GED and 12 years.
Preferred Qualifications
- Advertising and promotions technical authority; applies promotional regulations in a changing environment.
- Experience with negotiation, persuasion, collaboration, analytical judgment.
- Understands and applies data/information.
- Leadership, strategic focus, collaboration, independence, clinical knowledge, analytical judgment, negotiation/persuasion, coaching/mentoring, project management, problem solving, time management, organization.
Benefits
- Total Rewards Plan (health/welfare plans, financial plans, work/life balance, career development), including retirement/savings plan, medical/dental/vision, life/disability, flexible spending, discretionary annual bonus/incentive plan (as applicable), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number is received or a candidate is selected.