Bristol Myers Squibb is seeking an Associate Director for their GRS-CMC department in Warsaw, Poland. The role involves providing regulatory expertise for CMC activities throughout a product's lifecycle, requiring a deep understanding of biologics, small molecules, and cell therapy
Job Summary
The role involves developing global regulatory CMC strategies and leading submissions for biologics and cell therapy products.
Candidates will serve as the primary interface between Global Regulatory Sciences and Product Development teams to ensure regulatory success.
Bristol Myers Squibb offers competitive benefits, flexible work environments, and opportunities to transform patients' lives through science.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking an Associate Director for their GRS-CMC department in Warsaw, Poland. The role involves providing regulatory expertise for CMC activities throughout a product's lifecycle, requiring a deep understanding of biologics, small molecules, and cell therapy.
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
Knowledge of biologics and cell therapy
Global regulatory submission management
Manufacturing change control assessment
Nice-to-have
Experience with small molecule modalities
Strong project management techniques
Ability to lead matrix teams
Continuous improvement mindset
Excellent communication skills
Key Requirements
Minimum BA/BS Degree required
8+ years in Pharmaceutical industry
5+ years in CMC regulatory strategy
Expertise in biologics and cell therapy development