Regulatory Affairs Director

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Job Description
At Cpl Life Sciences, we are seeking an experienced Regulatory Affairs Director to lead our global regulatory strategies. This role will be responsible for providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.

Key Responsibilities:
  • Lead client projects, providing regulatory advice on filing routes, timings, and regulatory authority interactions.
  • Preparation of regulatory submission documents, including orphan drug designation applications and marketing authorisation applications.
  • Lead regulatory agency interactions/negotiations to ensure client goals are met.
  • Complete Senior Quality Control (QC) review as required.
  • Lead on complex, multifactorial regulatory projects requiring input from several functions.

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


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