Manager/senior Manager Regulatory Affairs – Advertising, Labeling, And Promotion

Beam Therapeutics

Cambridge, MA, United States
Base: $130,000 - $190,000 usd; bonus/equity: not s...
On-site
Promotional regulatory strategy
Promotional review committee (prc/mlr)
Fda promotional regulations
Beam Therapeutics is seeking a Manager/Senior Manager of Regulatory Affairs focused on advertising, labeling, and promotion, to drive U.S. promotional regulatory strategies and ensure compliance across their gene editing portfolio. The ideal candidate will have significant experience in regulatory advertising and promotion, particularly with FDA guidelines

Job Summary

  • Responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S. needs across our gene editing portfolio.
  • Ensures compliant, compelling, and scientifically accurate communications consistent with core labeling and regulatory requirements.
  • Monitors FDA OPDP/CBER guidance's, enforcement trends, and evolving U.S. regulations; educates internal teams.

Matching Summary

Match Score: 85

Beam Therapeutics is seeking a Manager/Senior Manager of Regulatory Affairs focused on advertising, labeling, and promotion, to drive U.S. promotional regulatory strategies and ensure compliance across their gene editing portfolio. The ideal candidate will have significant experience in regulatory advertising and promotion, particularly with FDA guidelines.

Salary

Base: $130,000 - $190,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • promotional regulatory strategy
  • promotional review committee (PRC/MLR)
  • FDA promotional regulations
  • 2253 submission experience
  • scientific substantiation

Nice-to-have

  • cutting-edge science
  • values-driven organization
  • life-long cures

Key Requirements

  • 8+ years (Manager) 10+ years (Senior Manager) experience
  • Bachelor's degree in a scientific discipline
  • Hands-on PRC/MLR experience
  • 2253 submission experience

Work Rights

Not specified

Tailored Resume

Cover Letter