Senior Manager To Associate Director, Regulatory Cmc

BeOne Medicines

Market competitive compensation; performance-based...
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3+ years pharmaceutical regulatory cmc experience
Authoring complex technical documents and ctd sections
Knowledge of ich requirements and usp/ep/jp regulations
** BeOne Medicines is seeking a Senior Manager to Associate Director in Regulatory CMC to support regulatory submissions and strategies for their oncology products in Japan. The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry, particularly in managing complex CMC submissions. Strong communication skills and a collaborative mindset are essential, as the role involves working with cross-functional teams. **

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 Japan-specific regulatory CMC submission strategies.
  • Employees receive a competitive compensation package including performance-based annual bonus, generous equity grants, and comprehensive benefits.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Manager to Associate Director in Regulatory CMC to support regulatory submissions and strategies for their oncology products in Japan. The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry, particularly in managing complex CMC submissions. Strong communication skills and a collaborative mindset are essential, as the role involves working with cross-functional teams. **

Salary

Market competitive compensation; Performance-based annual bonus scheme; Generous welcome grant and performance-based annual equity plan

Skills & Requirements

Must-have

  • 3+ years pharmaceutical regulatory CMC experience
  • Authoring complex technical documents and CTD sections
  • Knowledge of ICH requirements and USP/EP/JP regulations
  • Experience with MHLW/PMDA queries response
  • Strong oral and written communication skills

Nice-to-have

  • Familiarity with Veeva Vault system
  • Experience with FD system and Open Trusty/Open Approval
  • 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
  • Expertise in at least one area of pharmaceutical development
  • Not specified

Work Rights

Not specified

Tailored Resume

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