Associate Director, Global Regulatory Affairs Ad-promo (immuno-oncology)

Sanofi

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
Onsite
Regulatory leadership for ad-promo
Fda regulations for prescription drugs
Review committee (rc) leadership
The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies

Job Summary

  • The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies.
  • Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials, working directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
  • Sanofi offers endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally, with a thoughtful, well-crafted rewards package and comprehensive health and wellbeing benefits.

Matching Summary

The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Employees may be eligible to participate in Company employee benefit programs

Skills & Requirements

Must-have

  • Regulatory leadership for Ad-Promo
  • FDA regulations for prescription drugs
  • Review Committee (RC) leadership
  • Labeling and advertising material review
  • Cross-functional team collaboration

Nice-to-have

  • AI-powered research environment
  • Deep immunoscience understanding
  • Innovative pipeline development
  • Customer focus and negotiation skills

Key Requirements

  • 5+ years pharmaceutical Regulatory Affairs experience
  • 3+ years advertising & promotion experience
  • Bachelor's degree in Life Sciences
  • Leadership, mentoring, or training experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter