Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Amgen(3 months ago)
About this role
The Regulatory Affairs Senior Director - Global Regulatory Leader for Obesity will provide global regulatory leadership for Amgen’s obesity therapeutic area, guiding development, registration, and lifecycle management of prioritized assets. The role leads global regulatory teams and represents Global Regulatory Affairs on product and commercialization governance bodies to drive approval and target labeling for complex late-stage programs. This position develops and implements comprehensive regulatory strategies, manages regulatory agency interactions, and advises cross-functional teams on global regulatory risks and pathways.
Required Skills
- Regulatory Strategy
- Global Regulatory
- Team Leadership
- Regulatory Filings
- Labeling Strategy
- Regulatory Submissions
- Risk Assessment
- Communication Skills
- Negotiation Skills
- Clinical Development
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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