Director, Regulatory Strategist, Global Regulatory Affairs

Bristol Myers Squibb

Cambridge Crossing, US
Cambridge crossing: $240,940 - $291,964; madison -...
50% onsite
Global regulatory strategy development
Lead cross-functional teams
Negotiate regulatory objectives with health authorities
Develop and lead Global and US Regulatory activities for a Development Team(s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement

Job Summary

  • Develop and lead Global and US Regulatory activities for a Development Team(s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.
  • Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment, offering a wide variety of competitive benefits, services and programs.

Matching Summary

Develop and lead Global and US Regulatory activities for a Development Team(s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.

Salary

Cambridge Crossing: $240,940 - $291,964; Madison - Giralda - NJ - US: $215,130 - $260,683; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Lead cross-functional teams
  • Negotiate regulatory objectives with Health Authorities
  • Develop and execute regulatory filings
  • Manage external regulatory resources

Nice-to-have

  • Communicate with clarity and honesty
  • Seek multiple perspectives
  • Demonstrate ownership of results
  • Apply unique ideas and new methods
  • Create an environment for continuous improvement

Key Requirements

  • > 4-7 years regulatory affairs experience
  • Ph.D., M.D., PharmD, MS, or BS degree
  • Proven success in global regulatory strategies
  • Experience leading cross functional matrix teams
  • Proven success in negotiating regulatory objectives with HA

Work Rights

Not specified

Tailored Resume

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