Regulatory Affairs Director CMC – London

  • Permanent
  • London
  • Negotiable GBP / Year

Job title: Regulatory Affairs Director CMC – London

A global Pharmaceutical company in Central London are seeking a Regulatory Affairs Director CMC. The role will work across a portfolio of either small molecule or biologic products. The role will lead key, strategic CMC regulatory activities for investigational and/or early commercial products.

Responsibilities:

  • Serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
  • May have direct line management responsibility.
  • May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
  • Delivers CMC regulatory strategy to support major inspections (eg PAI’s) or quality incidents (PIRCs).

Requirements:

  • Biological sciences degree
  • Minimum 7 years of direct CMC Regulatory experience required
  • Line management experience is desirable

Salary and benefits:

A highly competitive salary, annual bonus, car allowance and LTI package is on offer with this role.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

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