Senior Manager, Regulatory Cmc

BeOne

Market competitive compensation; performance-based...
**
3+ years pharmaceutical regulatory cmc experience
Authoring complex technical documents and ctd sections
Knowledge of ich usp ep jp regulatory requirements
** BeOne, a global oncology company, is seeking a Senior Manager, Regulatory CMC, to oversee regulatory projects and submissions for both small molecules and biologics, with a focus on Japan's regulatory requirements. The ideal candidate will have significant experience in regulatory CMC within the pharmaceutical industry and will contribute to BeOne's mission of making cancer treatments more accessible worldwide. **

Job Summary

  • BeOne is a global oncology company committed to radically improving access to affordable medicines for cancer patients worldwide.
  • The role involves managing both small molecule and biologics products while developing strategies for Japan regulatory CMC submissions.
  • Employees receive a competitive compensation package including performance-based annual bonuses, company shares, and extensive learning opportunities.

Matching Summary

Match Score: 75

** BeOne, a global oncology company, is seeking a Senior Manager, Regulatory CMC, to oversee regulatory projects and submissions for both small molecules and biologics, with a focus on Japan's regulatory requirements. The ideal candidate will have significant experience in regulatory CMC within the pharmaceutical industry and will contribute to BeOne's mission of making cancer treatments more accessible worldwide. **

Salary

Market competitive compensation; Performance-based annual bonus scheme; Company shares welcome grant included

Skills & Requirements

Must-have

  • 3+ years pharmaceutical regulatory CMC experience
  • Authoring complex technical documents and CTD sections
  • Knowledge of ICH USP EP JP regulatory requirements
  • Experience with MHLW PMDA queries response
  • Expertise in chemical process formulation manufacturing QC QA

Nice-to-have

  • Familiarity with Veeva Vault system
  • Experience with FD Open Trusty Gateway systems
  • Knowledge of GMP regulation and post-approval submissions
  • Detail-oriented self-motivated professional
  • Comfortable in fast-paced entrepreneurial environment

Key Requirements

  • BA/BS Degree in scientific disciplines (MS/PhD preferred)
  • 3+ years related pharmaceutical regulatory CMC experience
  • Proven record in market applications and HA query response
  • Fluency in English and Japanese for document preparation

Work Rights

Not specified

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