Regulatory Affairs Director

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Job Title: Associate Director, Regulatory Affairs

Job Type: Permanent, full-time

Locations: Cambridge, UK – Hybrid/Remote

Remuneration: £85,000 - £110,000 + benefits

Cpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to lead our global regulatory strategy. As a key member of our team, you will be responsible for developing and implementing regulatory strategies for our clients, ensuring compliance with regulatory guidelines and facilitating early market access.

Key Responsibilities:

  • Lead client projects, providing strategic regulatory advice and guidance on regulatory submissions, including orphan drug designation applications, scientific advice briefing documents, and marketing authorisation applications.
  • Prepare and submit regulatory documents, including Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications, Paediatric Investigation Plans (PIPs)/Pediatric Study Plans (PSPs), and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation (BTD/RMAT) applications.
  • Lead regulatory agency interactions and negotiations to ensure client goals are met.
  • Complete Senior Quality Control (QC) review as required.
  • Lead complex, multifactorial regulatory projects requiring input from several functions and take necessary actions to highlight and mitigate potential risks to timelines, budget, and deliverables for clients.
  • May act as Subject Matter/Functional Area Expert.
  • Provide support to all ongoing projects and business activities as required, including mentoring of other members of the team as appropriate, and business development activities as needed.
  • Maintain up-to-date regulatory knowledge and contribute to the company's regulatory intelligence function.

Qualification Requirements:

  • Minimum of a B.Sc. in a life sciences subject and/or a higher degree.
  • At least 10 years of industry experience in a regulatory role required.
  • Prior experience in a CRO/pharmaceutical environment required.
  • Extensive experience driving global regulatory strategies.

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