Director - Regulatory Cmc

RayzeBio

Remote, United States
Base: $210,572 - $255,164 (remote us); $227,418 - ...
Fully remote
Radiopharmaceutical therapy experience required
Authoring ind impd nda maa dmf sections
Cmc global regulatory strategy execution
RayzeBio, a subsidiary of Bristol Myers Squibb, is seeking a Director of Regulatory Affairs - CMC to lead the global regulatory strategy for its radiopharmaceutical therapies. The role requires extensive experience in regulatory submissions and requires a candidate who thrives in a collaborative, dynamic environment

Job Summary

  • This role involves developing and executing the global CMC regulatory strategy for RayzeBio radiopharmaceutical drugs to secure successful approvals.
  • The position requires leading Health Authority meetings, managing technology transfer activities, and ensuring compliance with global regulatory standards.
  • Candidates will join a multidisciplinary team at a subsidiary of Bristol Myers Squibb, offering competitive compensation and comprehensive benefits including health coverage and flexible time off.

Matching Summary

Match Score: 85

RayzeBio, a subsidiary of Bristol Myers Squibb, is seeking a Director of Regulatory Affairs - CMC to lead the global regulatory strategy for its radiopharmaceutical therapies. The role requires extensive experience in regulatory submissions and requires a candidate who thrives in a collaborative, dynamic environment.

Salary

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

Skills & Requirements

Must-have

  • Radiopharmaceutical therapy experience required
  • Authoring IND IMPD NDA MAA DMF sections
  • CMC global regulatory strategy execution
  • Health Authority meeting leadership
  • Technology transfer regulatory alignment

Nice-to-have

  • Strong cross-functional collaboration skills
  • Adaptability in dynamic start-up environment
  • Proactive professional ethics and integrity
  • Experience with radiochemistry innovation
  • Ability to manage complex projects independently

Key Requirements

  • Bachelor's degree in chemistry or related field
  • 7+ years hands-on regulatory experience with Master's degree
  • 5+ years hands-on regulatory experience with advanced degree
  • Prior experience with radiopharmaceutical therapy or PET drug products
  • Demonstrable record of independent authoring of regulatory submissions

Work Rights

Not specified

Tailored Resume

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