Senior Manager to Associate Director, Regulatory CMC
BeOne Medicines(2 months ago)
About this role
BeOne is a global oncology company developing innovative and more accessible cancer therapies worldwide. This Regulatory CMC role supports the company's Japan regulatory programs, helping align local requirements with global development plans. The position partners with global and local stakeholders to enable timely regulatory readiness for clinical and marketing filings in Japan.
Required Skills
- CMC Regulatory
- Regulatory Strategy
- CTD
- Dossier Preparation
- Gap Analysis
- Risk Assessment
- Change Control
- GMP Knowledge
- PMDA Interaction
- Veeva Vault
+2 more
Qualifications
- BA/BS Degree
- MS/PhD Preferred
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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