Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
American Association of Physicists in Medicine(1 month ago)
About this role
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution at AstraZeneca Alexion is responsible for developing and maintaining regulatory strategies to achieve approval and lifecycle management of complex rare-disease products. The role operates within global development programs, providing strategic input and serving as the primary US regulatory interface to align regional and global business objectives and regulatory interactions.
Required Skills
- Regulatory Strategy
- FDA Interactions
- Submission Leadership
- Risk Assessment
- Cross-Functional Collaboration
- Regulatory Policy
- Project Management
- Scientific Judgment
- Communication
Qualifications
- Bachelor's Degree in Life Science
- MSc
- PhD
- PharmD
- MD
About American Association of Physicists in Medicine
aapm.orgN/A
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