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Global CMC Regulatory Affairs Associate Director

Global CMC Regulatory Affairs Associate Director

  • Location

    Oxfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    20687_1588084638

  • Published:

    5 months ago

  • Expiry date:

    2020-05-28

  • Consultant:

    #

Job title: Global Regulatory Affairs Associate Director CMC

A growing Pharmaceutical company in Oxfordshire are seeking a Global CMC Regulatory Affairs Associate Director to join their CMC teams. This role will have the opportunity to work on exciting development and marketed products on a global scale.

Responsibilities:

  • Plan and co-ordinate the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions
  • Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues.
  • Interact with cross functional leaders on matters concerning the regulatory affairs business unit
  • Coordinate the preparation and timely submission of responses to regulatory agencies

Requirements:

  • Minimum of eight years of regulatory CMC, knowledge of biotechnology products, including multi-disciplined experience required
  • Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
  • Educated to a degree level (Life Science ideally)

Salary and benefits:

A highly competitive annual salary, annual bonus, private healthcare and pension plan is on offer

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