Sr Associate Regulatory Affairs
Amgen(1 day ago)
About this role
The Local Regulatory Representative (Sr. Associate) manages regulatory requirements, submissions, and interactions with authorities for Amgen products, ensuring compliance with local and corporate standards. They coordinate regulatory strategies, oversee label development, and serve as the point of contact with regulatory agencies to support product approvals and lifecycle management.
Required Skills
- Regulatory Affairs
- Clinical Trial Applications
- Labeling
- Regulatory Strategy
- Lifecycle Management
- Regulatory Submissions
- Agency Interaction
- Drug Development
- Compliance
- Legislation
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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