Regulatory Affairs Manager - Oncology and Regulatory Promotion
Amgen
September 03, 2026
Remote friendly (United States)
United States
Corporate Functions
Regulatory Affairs Manager - Oncology and Regulatory Promotion
What You Will Do
Responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state.
Responsibilities:
- Provide strategic direction for product and disease communications by interpreting the regulatory environment to ensure truthful and non-misleading communication to healthcare community, patients, and the public.
- Serve as regulatory advertising and promotion lead for approved and/or pipeline Oncology products and disease state.
- Ensure deliverables align with the product label, comply with US FDA regulations and guidance, and adhere to Amgen SOPs and policies.
- Identify opportunities and challenges impacting US product strategy based on evolving competition, regulatory environment, and clinical data.
- Evaluate appropriate levels of evidence to make product claims.
- Mentor manager-level promotional reviewers.
Basic Qualifications:
- Doctorate degree
OR Master’s degree + 2 years industry experience
OR Bachelor’s degree + 4 years industry experience
OR Associate’s degree + 8 years industry experience
OR High school diploma/GED + 10 years industry experience
Preferred Qualifications:
- 2 years experience in Oncology
- Experience interpreting government regulations, policies, and guidance
- Strong clinical data analysis skills
- Ability to use judgment and data to formulate and communicate positions on complex issues
- Experience collaborating within large cross-functional teams
Total Rewards Plan (based on eligibility): Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending, discretionary bonus (or sales incentive plan), stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions: Apply at careers.amgen.com; no application deadline (accepted until a sufficient number/select a candidate). Sponsorship not guaranteed. You may redact age-identifying information.
What You Will Do
Responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state.
Responsibilities:
- Provide strategic direction for product and disease communications by interpreting the regulatory environment to ensure truthful and non-misleading communication to healthcare community, patients, and the public.
- Serve as regulatory advertising and promotion lead for approved and/or pipeline Oncology products and disease state.
- Ensure deliverables align with the product label, comply with US FDA regulations and guidance, and adhere to Amgen SOPs and policies.
- Identify opportunities and challenges impacting US product strategy based on evolving competition, regulatory environment, and clinical data.
- Evaluate appropriate levels of evidence to make product claims.
- Mentor manager-level promotional reviewers.
Basic Qualifications:
- Doctorate degree
OR Master’s degree + 2 years industry experience
OR Bachelor’s degree + 4 years industry experience
OR Associate’s degree + 8 years industry experience
OR High school diploma/GED + 10 years industry experience
Preferred Qualifications:
- 2 years experience in Oncology
- Experience interpreting government regulations, policies, and guidance
- Strong clinical data analysis skills
- Ability to use judgment and data to formulate and communicate positions on complex issues
- Experience collaborating within large cross-functional teams
Total Rewards Plan (based on eligibility): Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending, discretionary bonus (or sales incentive plan), stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions: Apply at careers.amgen.com; no application deadline (accepted until a sufficient number/select a candidate). Sponsorship not guaranteed. You may redact age-identifying information.