Senior Manager To Associate Director, Regulatory Cmc

BeOne Medicines Ltd

Japan, Japan
Cmc regulatory submissions
Japan regulatory cmc requirements
Ctd m1.2/m2.3 preparation
BeOne is a global oncology company dedicated to discovering and developing innovative, affordable, and accessible cancer treatments worldwide

Job Summary

  • BeOne is a global oncology company dedicated to discovering and developing innovative, affordable, and accessible cancer treatments worldwide.
  • This role involves managing, evaluating, and completing regulatory projects, with a focus on developing strategies, planning, drafting, and managing CMC-related regulatory submissions for the Japan market.
  • The company offers a market-competitive compensation package, company shares, in-house and external learning opportunities, and a fantastic benefits program.

Matching Summary

BeOne is a global oncology company dedicated to discovering and developing innovative, affordable, and accessible cancer treatments worldwide.

Skills & Requirements

Must-have

  • CMC regulatory submissions
  • Japan regulatory CMC requirements
  • CTD M1.2/M2.3 preparation
  • Health Authority interaction support
  • Manufacturing license management

Nice-to-have

  • Collaborative team environment
  • Entrepreneurial mindset
  • Continuous learning and development
  • Passion for fighting cancer

Key Requirements

  • 3+ years of regulatory CMC experience
  • Experience in authoring CTD sections
  • Knowledge of ICH requirements
  • Knowledge of GMP regulation
  • BA/BS Degree in scientific disciplines

Work Rights

Not specified

Tailored Resume

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