Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)
Amgen · Thousand Oaks, CA
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Director of Global Regulatory Affairs to lead regulatory strategy for obesity and metabolic disease programs. The role requires developing global submission strategies, directing cross-functional teams, and managing interactions with health authorities across multiple regions.
What they're looking for
- Doctorate degree with 4+ years regulatory experience, or Master's degree with 7+ years, or Bachelor's degree with 9+ years
- 8–10+ years global regulatory experience with leadership of metabolic disorder or obesity programs
- Scientific expertise in metabolism, energy balance physiology, hormone signaling, and cardiometabolic endpoints
- Experience developing global submissions and leading FDA, EMA, and other health authority interactions
- Demonstrated success leading regulatory teams and influencing governance on complex clinical development issues
- Ability to translate metabolic science into actionable regulatory strategy for cross-functional alignment
What you'll be doing
- Develop and execute global regulatory strategies for obesity and metabolic disease programs, including Global Regulatory Strategic Plans with risk assessment and pathway evaluation
- Lead Global Regulatory Team and represent regulatory affairs on cross-functional teams to ensure strategy execution and alignment
- Oversee major global regulatory submissions including clinical trial applications, marketing applications, and labeling updates
- Lead strategy development and health authority engagement with FDA, EMA, PMDA, NMPA on metabolic disorders and clinical development elements
- Build, mentor, and develop high-performing global regulatory teams with expertise in metabolic disease science
Privacy & handoff
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