Specialist I/ii, Regulatory Affairs

Beam Therapeutics

Cambridge, MA, United States
Base: $130,000 - $160,000 usd; bonus/equity: not s...
On-site
Prepare global regulatory submission documentation
Support regulatory strategy development
Monitor regulatory guidelines and trends
Beam Therapeutics is seeking a Regulatory Specialist I/II to support global regulatory submissions in a biotechnology environment focused on precision genetic medicines. The ideal candidate will have extensive regulatory experience, particularly in CMC, and a strong understanding of FDA and international guidelines

Job Summary

  • The Regulatory Specialist will participate in the preparation of documentation packages for global regulatory submissions.
  • Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape.
  • Develops and maintains collaborative partnerships with key internal and external stakeholders.

Matching Summary

Match Score: 85

Beam Therapeutics is seeking a Regulatory Specialist I/II to support global regulatory submissions in a biotechnology environment focused on precision genetic medicines. The ideal candidate will have extensive regulatory experience, particularly in CMC, and a strong understanding of FDA and international guidelines.

Salary

Base: $130,000 - $160,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Prepare global regulatory submission documentation
  • Support regulatory strategy development
  • Monitor regulatory guidelines and trends
  • Collaborate with internal and external stakeholders

Nice-to-have

  • Cell and gene experience
  • Diverse filing experience
  • Creative problem-solving approach

Key Requirements

  • BA/BS degree in scientific/engineering discipline
  • 6+ years' experience in biotech industry
  • 8-10+ years' experience in Regulatory CMC
  • Comprehensive knowledge of FDA, EMA, and ICH guidelines
  • Strong experience with CTD format

Work Rights

Not specified

Tailored Resume

Cover Letter