Regulatory Affairs Senior Manager (CMC)
Amgen(5 months ago)
About this role
The RA CMC Senior Manager leads and coordinates global regulatory CMC activities for an assigned portfolio of commercial products, providing leadership and strategic input on regulatory filings and strategy. The role communicates regulatory strategy, risks, and issues to senior management and ensures alignment across site and regional CMC representatives. It is focused on implementing global regulatory approaches and supporting cross-functional collaboration to maintain compliance and product supply.
Required Skills
- Regulatory CMC
- Regulatory Strategy
- Risk Assessment
- Submissions
- Stakeholder Management
- Staff Management
- Coaching
- RIM
- Compliance
- Supply Alignment
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
- Associate's Degree
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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