Senior Manager To Associate Director, Regulatory Cmc

BeOne

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

Job Summary

  • BeOne is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
  • This role is responsible for the development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet aggressive timelines.
  • The company offers a market-competitive compensation package including performance-based annual bonus, company shares, and extensive learning and development opportunities.

Matching Summary

BeOne is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.

Skills & Requirements

Must-have

  • CMC regulatory submissions
  • Japan regulatory CMC
  • CTD M1.2/M2.3 authoring
  • Health Authority interactions
  • GMP regulation knowledge

Nice-to-have

  • Entrepreneurial, fast-paced environment
  • Collaborative, supportive team
  • Continuous learning opportunities
  • Passionate interest in fighting cancer

Key Requirements

  • 3+ years of regulatory CMC experience
  • Experience in market applications
  • Experience authoring technical documents
  • Knowledge of ICH requirements
  • BA/BS Degree in scientific disciplines

Work Rights

Not specified

Tailored Resume

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