Associate Director, Regulatory Affairs, CMC
BeOne Medicines(9 days ago)
About this role
BeOne is seeking an experienced Regulatory Affairs CMC professional to develop and implement global regulatory strategies for biologics throughout their lifecycle. The role involves managing interactions with regulatory agencies, preparing submission content, and supporting both development and commercialization phases.
Required Skills
- Regulatory Affairs
- CMC Strategy
- Biologics
- Regulatory Submissions
- GMP
- Documentation
- Project Management
- FDA
- global regulation
- Team Collaboration
Qualifications
- BS/BA in Biochemistry, Biology, or Pharmaceutical Science
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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