Associate Director, Commercial Regulatory Affairs

Bristol Myers Squibb

Princeton, NJ, United States
Base: $173,350 - $210,058; bonus/equity: + incenti...
50% onsite
Promotional material risk assessment
Regulatory advice for commercial teams
Ensure compliance with fda regulations
The role requires applying complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials to ensure company objectives are met

Job Summary

  • The role requires applying complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials to ensure company objectives are met.
  • Responsibilities include providing regulatory advice, risk assessment, and mitigation strategies to various internal groups on all promotional materials, ensuring compliance with approved labeling and FDA guidances.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Matching Summary

The role requires applying complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials to ensure company objectives are met.

Salary

Base: $173,350 - $210,058; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Promotional material risk assessment
  • Regulatory advice for commercial teams
  • Ensure compliance with FDA regulations
  • Develop regulatory strategies for campaigns
  • Analyze efficacy and safety data

Nice-to-have

  • Solution-oriented and innovative advice
  • Adaptable to changing environments
  • Strong working relationships with internal customers
  • Pursues diverse perspectives

Key Requirements

  • BS required; advanced degree preferred
  • 3-5 years Regulatory promotional review
  • 5-8 years pharmaceutical experience
  • Experience with FDA advertising and promotion regulations
  • Experience negotiating with OPDP

Work Rights

Not specified

Tailored Resume

Cover Letter