Regulatory Affairs Manager
Amgen(2 years ago)
About this role
The Local Regulatory Representative (Manager) at Amgen provides country-level regulatory expertise for assigned product programs, focusing on development, registration, and lifecycle management. The role ensures alignment between local regulatory environments and Amgen’s corporate regulatory framework and represents the company in interactions with national health authorities and local partners. It operates within regional and global networks to inform regulatory decisions and support compliant market access for medicines.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- Labeling
- Clinical Trials
- Agency Interaction
- Compliance
- Vendor Management
- Communication
- Negotiation
- Regulatory Intelligence
+1 more
Qualifications
- Doctorate in Scientific Area
- Master's Degree in Scientific Area
- Bachelor's Degree in Scientific Area
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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