Senior Manager Ii, Grs - Cmc, Biologics

Bristol Myers Squibb

Warsaw, Poland
Base: zł321,730 - zł389,865; bonus/equity: + incen...
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4+ years cmc regulatory experience
Knowledge of biologics and cell therapy
Global regulatory submission management
** Bristol Myers Squibb is seeking a Senior Manager II for their GRS-CMC team in Warsaw, Poland, focusing on regulatory expertise related to CMC activities for biologics and advanced therapies. The ideal candidate will have extensive experience in regulatory compliance and strong communication skills, with the opportunity to thrive in a collaborative and innovative work environment. **

Job Summary

  • The role involves developing global regulatory CMC strategies and leading submissions for clinical trials and marketing applications.
  • Candidates will serve as the primary interface between Global Regulatory Sciences, Product Development, and Supply teams to ensure regulatory success.
  • Bristol Myers Squibb offers a competitive benefits package including flexible work arrangements and opportunities for career growth in life-changing science.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Senior Manager II for their GRS-CMC team in Warsaw, Poland, focusing on regulatory expertise related to CMC activities for biologics and advanced therapies. The ideal candidate will have extensive experience in regulatory compliance and strong communication skills, with the opportunity to thrive in a collaborative and innovative work environment. **

Salary

Base: zł321,730 - zł389,865; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs provided

Skills & Requirements

Must-have

  • 4+ years CMC regulatory experience
  • Knowledge of biologics and cell therapy
  • Global regulatory submission management
  • Manufacturing change control assessment
  • Health authority interaction

Nice-to-have

  • Experience with advanced therapies
  • Strong cross-functional leadership
  • Solution-oriented mindset
  • Electronic dossier system proficiency
  • Strategic risk mitigation skills

Key Requirements

  • Minimum BA/BS degree required
  • 4-6+ years pharmaceutical experience
  • 4+ years CMC regulatory experience
  • Knowledge of small molecules and biologics
  • Ability to interpret global regulations

Work Rights

Not specified

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