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 focuses on developing and driving regulatory strategies for complex therapies, requiring extensive experience in CMC regulatory strategy and strong leadership capabilities

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 global change management policies for manufacturing processes.

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 focuses on developing and driving regulatory strategies for complex therapies, requiring extensive experience in CMC regulatory strategy and strong leadership capabilities.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits 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 systems familiarity
  • Strategic leadership in oncology
  • Process improvement mindset
  • High standards of ownership

Key Requirements

  • BA/BS degree required (advanced scientific or regulatory degree preferred)
  • Minimum 8 years pharmaceutical industry experience
  • At least 5 years in CMC regulatory strategy
  • Proven track record leading cross-functional projects

Work Rights

Not specified

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