Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology
Amgen
August 14, 2026
On-site
United States
Corporate Functions
Senior Director, Regulatory Affairs – Global Regulatory Leader (Oncology)
What You Will Do / Key Responsibilities
- Develop and execute global regulatory product strategies for late-stage, highly complex oncology programs to achieve approval and target labeling.
- Lead Global Regulatory Teams (GRTs) and provide regulatory leadership to cross-functional teams.
- Represent Global Regulatory Affairs on product teams and commercialization governance bodies.
- Develop the Global Regulatory Strategic Plan and regulatory inputs to the product’s Global Strategic Plan; identify and communicate regulatory risks.
- Provide regulatory direction for core data sheet development; ensure evidence-based global product communication.
- Plan and implement global regulatory filings (e.g., CTAs, marketing applications, label extensions).
- Monitor regulatory guidance/environment impacts; advise on implications.
- Assess mechanisms to optimize development (e.g., Orphan Drug Designation, Fast Track, conditional/accelerated approval, compassionate use, pediatric plan) and incorporate into strategy.
- Lead strategy/approach for regulatory agency interactions; communicate risks/mitigations/contingencies.
- Lead external partnership regulatory representation and regulatory process improvements/initiatives.
Qualifications
Basic:
- Doctorate + 5 years regulatory experience in biotech/science; OR Master’s + 9 years; OR Bachelor’s + 11 years.
- At least 5 years directly managing people and/or leading teams/projects/programs/resources.
Preferred:
- Contemporary oncology experience; proven leadership of late-development complex programs.
- Experience leading original marketing application/major indication supplement approvals.
- Ability to build teams; strong oral/written communication; scientific/clinical understanding; conflict resolution; cultural/global results; planning/organization; prioritization; problem-solving; deal with ambiguity; negotiation.
Benefits (as stated)
- Total Rewards Plan including comprehensive health/welfare, retirement/savings, bonus/incentives, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- No application deadline; applications accepted until sufficient number or selection of a candidate.
What You Will Do / Key Responsibilities
- Develop and execute global regulatory product strategies for late-stage, highly complex oncology programs to achieve approval and target labeling.
- Lead Global Regulatory Teams (GRTs) and provide regulatory leadership to cross-functional teams.
- Represent Global Regulatory Affairs on product teams and commercialization governance bodies.
- Develop the Global Regulatory Strategic Plan and regulatory inputs to the product’s Global Strategic Plan; identify and communicate regulatory risks.
- Provide regulatory direction for core data sheet development; ensure evidence-based global product communication.
- Plan and implement global regulatory filings (e.g., CTAs, marketing applications, label extensions).
- Monitor regulatory guidance/environment impacts; advise on implications.
- Assess mechanisms to optimize development (e.g., Orphan Drug Designation, Fast Track, conditional/accelerated approval, compassionate use, pediatric plan) and incorporate into strategy.
- Lead strategy/approach for regulatory agency interactions; communicate risks/mitigations/contingencies.
- Lead external partnership regulatory representation and regulatory process improvements/initiatives.
Qualifications
Basic:
- Doctorate + 5 years regulatory experience in biotech/science; OR Master’s + 9 years; OR Bachelor’s + 11 years.
- At least 5 years directly managing people and/or leading teams/projects/programs/resources.
Preferred:
- Contemporary oncology experience; proven leadership of late-development complex programs.
- Experience leading original marketing application/major indication supplement approvals.
- Ability to build teams; strong oral/written communication; scientific/clinical understanding; conflict resolution; cultural/global results; planning/organization; prioritization; problem-solving; deal with ambiguity; negotiation.
Benefits (as stated)
- Total Rewards Plan including comprehensive health/welfare, retirement/savings, bonus/incentives, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- No application deadline; applications accepted until sufficient number or selection of a candidate.