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Regulatory Affairs Director

2 months ago

Cambridge, Cambridgeshire, United Kingdom Relay Therapeutics Full time

The Opportunity:

We are seeking a seasoned regulatory affairs professional to lead our global regulatory strategy and ensure compliance with regulatory requirements. As a key member of our regulatory team, you will have the opportunity to develop and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline.

Your Role:

  • You will report to our Head of Regulatory Affairs and work closely with research and development colleagues to develop and execute regulatory strategies for our development programs.
  • You will be responsible for leading the preparation and submission of high-quality domestic and global regulatory submission documents, as well as developing response strategies to regulators.
  • You will communicate with global regulatory authorities and lead the preparation and conduct of meetings with health authorities, including the development of robust briefing packages and comprehensive meeting preparation.
  • You will integrate your knowledge of current legislation, guidelines, and regulatory intelligence into development strategies and ensure compliance with regulatory filing and reporting requirements.
  • You will proactively identify regulatory opportunities and risks and propose alternative approaches and mitigations to resolve development program challenges.
  • You will lead efforts to plan and obtain regulatory designations, including breakthrough therapy designations, fast-track designations, and orphan drug designations.
  • You will provide oversight to global regulatory activities performed by our Clinical Research Organization (CROs) and regulatory vendors.
  • You will lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.

Your Background:

  • You have earned your B.S. and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
  • You are results-oriented and have comprehensive knowledge of the drug development process and a demonstrated record of successful regulatory submissions.
  • Experience in precision oncology, rare disease, and/or companion diagnostic (CDx) is a plus.
  • You are a regulatory interpreter with experience in interpretation of regulations, guidelines, and policy statements.
  • You are a strategic thinker capable of proposing innovative solutions to regulatory problems.
  • You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management, and regulatory agencies.
  • You are self-motivated and driven with a proactive and flexible working style and a passion for impacting patients' lives through regulatory work.