Regulatory Affairs Manager - Oncology and Regulatory Promotion
Amgen · Remote
RegulatoryRemoteFull-timeCompany career page
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Role summary
Amgen seeks a Regulatory Affairs Manager to develop and communicate regulatory promotional strategies for oncology products. The role involves interpreting FDA regulations, ensuring compliant communications, and mentoring promotional reviewers across cross-functional teams.
What they're looking for
- Doctorate degree, or Master's degree with 2 years industry experience
- Interpretation of FDA regulations, policies, and guidance
- Strong clinical data analysis and evidence evaluation skills
- Experience formulating positions on complex regulatory issues
- Preferred: 2 years oncology experience
- Ability to collaborate across large cross-functional teams
What you'll be doing
- Formulate and communicate regulatory promotional positions for approved and pipeline oncology products
- Provide strategic direction for product and disease state communications aligned with regulatory environment
- Lead regulatory advertising and promotion activities ensuring FDA compliance and label consistency
- Identify competitive and regulatory opportunities impacting US product strategy
- Mentor manager-level promotional reviewers
Compensation$112,744 - $145,000 base
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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