Regulatory Affairs Manager (CMC)
Amgen(5 months ago)
About this role
The RA CMC Manager leads global regulatory chemistry, manufacturing, and controls (CMC) activities for assigned commercial products, ensuring regulatory strategies are defined and communicated. The role provides oversight and alignment across product teams and interfaces with senior management and regional/site representatives to support global regulatory execution.
Required Skills
- CMC
- Regulatory Strategy
- Dossier Development
- Change Management
- Risk Assessment
- Submission Preparation
- Health Authorities
- Cross-Functional Liaison
- RIM
- Quality Control
Qualifications
- Doctorate Degree
- Master’s Degree and 3 Years Directly Related Experience
- Bachelor’s Degree and 5 Years Directly Related Experience
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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