Director - Regulatory Cmc

Bristol Myers Squibb

United States
Base: $210,572 - $255,164 (remote us); $227,418 - ...
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Radiopharmaceutical therapy experience required
Ind impd nda maa dmf authoring experience
Global regulatory strategy development
** RayzeBio, a subsidiary of Bristol Myers Squibb, is seeking a Director of Regulatory Affairs - CMC to oversee regulatory functions for radiopharmaceutical therapies. The role requires extensive experience in regulatory submissions and cross-functional collaboration, with an emphasis on developing CMC regulatory strategies. **

Job Summary

  • This role involves developing and executing the global regulatory strategy for RayzeBio radiopharmaceutical drugs to secure IND, NDA, and MAA approvals.
  • The successful candidate will lead Health Authority meetings, manage complex projects, and ensure compliance with global regulatory standards for quality modules.
  • RayzeBio offers a competitive compensation package including health coverage, financial well-being programs, and flexible time off options.

Matching Summary

Match Score: 75

** RayzeBio, a subsidiary of Bristol Myers Squibb, is seeking a Director of Regulatory Affairs - CMC to oversee regulatory functions for radiopharmaceutical therapies. The role requires extensive experience in regulatory submissions and cross-functional collaboration, with an emphasis on developing CMC regulatory strategies. **

Salary

Base: $210,572 - $255,164 (Remote US); $227,418 - $275,577 (San Diego CA); Bonus/Equity: Incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Radiopharmaceutical therapy experience required
  • IND IMPD NDA MAA DMF authoring experience
  • Global regulatory strategy development
  • Health Authority meeting leadership
  • Cross-functional team management

Nice-to-have

  • Strong communication and interpersonal skills
  • Flexibility in dynamic start-up environment
  • Proactive and assertive professional demeanor
  • Participation in trade groups and conferences

Key Requirements

  • Bachelor's degree in chemistry or related field
  • Master's degree with 7+ years regulatory experience
  • Advanced degree with 5+ years regulatory experience
  • Prior radiopharmaceutical therapy product experience
  • Independent authoring of IND, IMPD, NDA, MAA sections

Work Rights

Not specified

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