Associate Director, Regulatory Cmc Cell And Gene Therapy

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: + incen...
Hybrid (50% onsite)
8+ years pharmaceutical industry experience
5+ years cmc regulatory strategy
Leading cross-functional matrix teams
Bristol Myers Squibb is seeking an Associate Director for Regulatory CMC in Cell and Gene Therapy, based in Warsaw, Poland. The role involves strategic oversight of regulatory CMC processes, driving drug development timelines, and enhancing patient outcomes through effective regulatory strategy

Job Summary

  • This role serves as the strategic bridge between the science of medicine production and global regulatory frameworks to ensure safe and efficient patient access.
  • You will own end-to-end CMC regulatory strategy, developing plans that directly influence drug development timelines and commercial outcomes across small molecules, biologics, and cell therapies.
  • The position offers a rare opportunity to lead high-stakes interactions with Health Authorities while shaping company-wide policies in a mission-driven environment focused on transforming patients' lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking an Associate Director for Regulatory CMC in Cell and Gene Therapy, based in Warsaw, Poland. The role involves strategic oversight of regulatory CMC processes, driving drug development timelines, and enhancing patient outcomes through effective regulatory strategy.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities available based on eligibility; Benefits: Wide variety of competitive benefits, services, and programs provided

Skills & Requirements

Must-have

  • 8+ years pharmaceutical industry experience
  • 5+ years CMC regulatory strategy
  • Leading cross-functional matrix teams
  • Global CMC regulatory requirements knowledge
  • Health Authority interaction experience

Nice-to-have

  • Experience with cell therapy products
  • Electronic dossier system familiarity
  • Strategic thinking and independent judgment
  • Clear communication and high standards
  • Process improvement and policy shaping

Key Requirements

  • BA/BS degree minimum (advanced scientific or regulatory degree preferred)
  • Track record of leading teams and managing competing priorities
  • Familiarity with electronic dossier systems and Regulatory Information Management tools
  • Ability to work independently on complex multi-faceted challenges

Work Rights

Not specified

Tailored Resume

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