Global Regulatory Strategy Director

3 weeks ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

**Job Title:** Global Regulatory Strategy Director

Location: Cambridge, UK – Hybrid/Remote

Rate: Negotiable (£80,000 - £110,000 per annum)

This role offers an exciting opportunity to lead the development of global regulatory strategies for a growing business that supports pharmaceuticals, biotechs, spin-outs, and academic groups.

As a Global Regulatory Strategy Director, you will provide strategic guidance on regulatory affairs, support all areas of development, and handle various regulatory tasks. The right profile will have a strong regulatory background with a keen interest in drug development and a desire to be hands-on with all regulatory activities.

Key Responsibilities:

  • Lead client projects, providing strategic regulatory advice while considering regulatory guidelines and measures to facilitate regulatory input, incentives, and early market access.
  • Prepare regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications, Paediatric Investigation Plans (PIPs)/Pediatric Study Plans (PSPs), PRIME/BTD/RMAT, 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, and take necessary actions to highlight and mitigate potential risks to timelines, budget, and deliverables for clients.
  • Provide support to ongoing projects and business activities as required, including mentoring of team members and participating in business development activities.

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.


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