Associate Director, Precision Medicine Digital Health

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: + incen...
50% onsite
Global regulatory strategies
Biomarkers and companion diagnostics
Digital health solutions
Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products

Job Summary

  • Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products.
  • Co-leads marketing application submission teams, ensures consistent responses to global Health Authority (HA) queries, and integrates regional regulatory strategies into global development plans.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment and offers a wide variety of competitive benefits, services and programs.

Matching Summary

Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Competitive benefits, services and programs

Skills & Requirements

Must-have

  • global regulatory strategies
  • biomarkers and companion diagnostics
  • digital health solutions
  • pharmaceutical product development
  • health authority interactions
  • cross-functional team leadership

Nice-to-have

  • patient life transformation
  • career growth opportunities
  • work-life balance and flexibility
  • collaboration and innovation

Key Requirements

  • 7+ years US or EU Medical Device Regulatory Affairs experience
  • Bachelor's degree required; advanced scientific degree preferred
  • Experience leading teams
  • Experience with clinical trial assays (CTA)
  • Experience with global regulatory requirements for drugs

Work Rights

Not specified

Tailored Resume

Cover Letter