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Regulatory Affairs Director

1 month ago

Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time
Regulatory Affairs Director Opportunity

Join Clinical Professionals Limited in a key role as a Regulatory Affairs Director, leading the development of global regulatory strategies for pharmaceutical and biotech clients.

About the Role:

  • Lead the development of regulatory strategies for global pharmaceutical and biotech clients.
  • Collaborate with cross-functional teams to ensure regulatory compliance and optimal product development.
  • Provide strategic regulatory advice to clients, considering regulatory guidelines and measures for regulatory input, incentives, and early market access.
  • Prepare regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, and marketing authorisation applications.
  • Lead regulatory agency interactions and negotiations to ensure client goals are met.
  • Stay up-to-date with the latest regulatory developments and contribute to the company's regulatory intelligence function.

Requirements:

  • At least 10 years of industry experience in a regulatory role.
  • Prior experience in a CRO/pharmaceutical environment.
  • Extensive experience driving global regulatory strategies.

What We Offer:

  • A dynamic and growing business with a strong focus on regulatory affairs.
  • A collaborative and supportive team environment.
  • Opportunities for professional development and growth.