Senior Manager, Cmc Regulatory

Bristol Myers Squibb UK

**
10+ years regulatory application experience
Ctd document creation expertise
Pmda consultation and negotiation skills
** Bristol Myers Squibb UK is seeking a Senior Manager for CMC Regulatory, a role that involves providing regulatory advice, leading cross-functional teams, and managing lifecycle activities for pharmaceutical products. The ideal candidate will have over ten years of relevant experience in regulatory affairs and a strong background in biopharmaceuticals. **

Job Summary

  • This role involves leading regulatory strategy and execution for pharmaceutical development and lifecycle management in Japan.
  • The position requires extensive experience creating CTD documents and managing interactions with the PMDA for JNDA/sJNDA approvals.
  • Bristol Myers Squibb offers a flexible work environment with competitive benefits designed to support employee goals both at work and personally.

Matching Summary

Match Score: 75

** Bristol Myers Squibb UK is seeking a Senior Manager for CMC Regulatory, a role that involves providing regulatory advice, leading cross-functional teams, and managing lifecycle activities for pharmaceutical products. The ideal candidate will have over ten years of relevant experience in regulatory affairs and a strong background in biopharmaceuticals. **

Skills & Requirements

Must-have

  • 10+ years regulatory application experience
  • CTD document creation expertise
  • PMDA consultation and negotiation skills
  • GMP/GCTP audit support capability
  • English communication for global teams

Nice-to-have

  • Biologics or cell therapy product knowledge
  • Strong coaching and leadership abilities
  • Experience with minor change notifications
  • Strategic risk assessment capabilities
  • Cross-functional team collaboration

Key Requirements

  • 10+ years of regulatory application practice
  • Expertise in Japanese Pharmacopoeia standards
  • Proven leadership and coaching skills
  • Advanced English negotiation proficiency

Work Rights

Not specified

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