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Regulatory Affairs Director

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

Job Summary

We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.

Key Responsibilities

  • Develop and execute global regulatory CMC strategy and submissions for assigned programs or projects.
  • Collaborate with internal colleagues and external organizations to develop submission content plans and timelines.
  • Manage the preparation, drafting, review, risk analysis, and mitigation planning of CMC submissions.
  • Develop and maintain internal cross-functional relationships to support the development and execution of CMC regulatory submissions.
  • May act as the Global/Regional CMC Regulatory Lead for assigned development programs.

Requirements

  • Bachelor's degree in a scientific field or post-graduate degree preferred.
  • Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations.
  • Experience and knowledge in preparation of CMC sections of INDs, CTAs, NDAs, MAAs, or regional equivalents is required.

What We Offer

  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment.
  • Competitive reward including annual company bonus.
  • Employee recognition schemes.