Regulatory Compliance Change Assessor - Manager
Amgen(1 month ago)
About this role
The Regulatory Compliance Change Assessor at Amgen reports to the Regulatory Compliance Team Lead and provides regulatory support for product changes across Global, Site, Biosimilars, and Device RA CMC teams. The role focuses on assessing reportability and distribution restrictions for single or cross-product changes and supporting product strategies in collaboration with Operations, Quality, and Supply Chain. This position contributes to regulatory alignment and supports professional development of junior regulatory staff.
Required Skills
- Change Assessment
- Reportability
- Regulatory CMC
- Cross-Functional Liaison
- Documentation
- Process Improvement
- Coaching
- Quality
- Supply Chain
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
- Diploma
- Degree in Life Science
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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