Associate Director, Regulatory Affairs

Relay Therapeutics

Cambridge, MA, United States
On-site
Global regulatory strategy development
Ind cta nda maa submission preparation
Fda and international authority interaction
Relay Therapeutics is seeking an Associate Director of Regulatory Affairs to lead innovative regulatory strategies for their development pipeline. The position involves interfacing with the FDA, preparing regulatory submissions, and ensuring compliance with regulatory requirements

Job Summary

  • The role involves defining and implementing innovative regulatory strategies to expedite the development and approval of transformative pipeline products.
  • You will serve as the primary contact for FDA interactions and lead cross-functional teams in delivering domestic and international regulatory submissions.
  • Responsibilities include leading meetings with health authorities, preparing briefing packages, and proactively identifying regulatory opportunities and risks.

Matching Summary

Match Score: 85

Relay Therapeutics is seeking an Associate Director of Regulatory Affairs to lead innovative regulatory strategies for their development pipeline. The position involves interfacing with the FDA, preparing regulatory submissions, and ensuring compliance with regulatory requirements.

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • IND CTA NDA MAA submission preparation
  • FDA and international authority interaction
  • Cross-functional team leadership
  • Regulatory designation acquisition

Nice-to-have

  • Experience with breakthrough therapy designations
  • CDx strategy development expertise
  • CRO and vendor oversight capabilities
  • Innovative regulatory approach implementation

Key Requirements

  • Experience with IND CTA NDA MAA submissions
  • Background in global regulatory affairs
  • Leadership experience in biotech or pharma

Work Rights

Not specified

Tailored Resume

Cover Letter