Senior Director Regulatory Affairs, CMC
BeOne Medicines(5 days ago)
About this role
BeOne is seeking an experienced regulatory leader to oversee the U.S. Biologics Regulatory CMC organization. The role involves strategic and operational leadership in biologics regulatory activities, ensuring compliance, managing submissions, and maintaining regulatory relationships across the product lifecycle. The position reports to the Global Head of Regulatory CMC and manages a substantial team, contributing to the development and execution of global CMC strategies.
Required Skills
- Regulatory Affairs
- CMC Strategy
- Regulatory Submissions
- Health Authority Liaison
- Biologics
- GMP
- ICH Guidelines
- Technical Documentation
- Leadership
- Veeva Vault
Qualifications
- BS in Scientific Disciplines
- MS/PhD (preferred)
- 12+ years pharmaceutical or biopharmaceutical experience
- 10+ years regulatory CMC experience
- Experience with biologics, cell therapy, gene therapy
About BeOne Medicines
beonemedicines.comBeOne Medicines, formerly BeiGene, is committed to developing innovative cancer medicines by partnering globally to serve patients everywhere.
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