Regulatory Affairs Mgr
Amgen(6 months ago)
About this role
The International Regulatory Lead (Manager) provides regulatory leadership and expertise for Amgen products across international countries, supporting product registrations and lifecycle activities. The role partners with global, regional and local teams to develop international regulatory strategy and align on submission and approval planning. It focuses on optimizing product development and regulatory outcomes across diverse regulatory environments.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- Labeling Strategy
- Clinical Trials
- Lifecycle Management
- Health Authority Liaison
- Regulatory Research
- Cross-Functional Collaboration
- Negotiation
- Communication
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
- Associate Degree
- High School Diploma/GED
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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