Senior Manager, Cmc Regulatory

Bristol Myers Squibb

**
10+ years regulatory application experience
Jnda/sjnda submission expertise
Ctd document creation and review
** Bristol Myers Squibb is seeking a Senior Manager for CMC Regulatory who will lead regulatory discussions and provide cross-functional support for drug development. The ideal candidate will have over ten years of practical experience in regulatory submissions, excellent negotiation skills, and a strong technical background in pharmaceuticals, with a commitment to ethical practices. **

Job Summary

  • This role involves leading regulatory strategy and execution for pharmaceutical products in Japan while collaborating with global teams.
  • The position requires creating and managing complex regulatory documents including CTNs, JNDAs, and CTD submissions for PMDA approval.
  • Employees will receive competitive benefits and opportunities to work on life-changing science alongside high-achieving cross-functional teams.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Senior Manager for CMC Regulatory who will lead regulatory discussions and provide cross-functional support for drug development. The ideal candidate will have over ten years of practical experience in regulatory submissions, excellent negotiation skills, and a strong technical background in pharmaceuticals, with a commitment to ethical practices. **

Skills & Requirements

Must-have

  • 10+ years regulatory application experience
  • JNDA/sJNDA submission expertise
  • CTD document creation and review
  • GMP/GCTP inspection support
  • English communication for global teams
  • Negotiation and leadership skills

Nice-to-have

  • Biopharmaceutical product experience
  • Regenerative medicine knowledge
  • Coaching and team development skills
  • Strategic risk assessment capabilities
  • Flexible adaptation to global changes

Key Requirements

  • 10+ years of regulatory application practice
  • Experience with JNDA and sJNDA submissions
  • Expertise in CTD creation and GMP inspections
  • Advanced English communication proficiency
  • Proven leadership and negotiation abilities

Work Rights

Not specified

Tailored Resume

Cover Letter