Regulatory Affairs Associate Director, Global Labelling

Regulatory Affairs Associate Director, Global Labelling

  • Location

    Oxfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:


  • Contact:

    Matt Thomas

  • Contact email:


  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


  • Consultant:


Job title: Regulatory Affairs Associate Director, Global Labelling

A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Associate Director, Global Labelling. Reporting directly into the Head of Global Labelling, this role will be responsible for both technical and operational support within Labelling across global markets.


  • Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
  • Under the direction of the Head of Global Labelling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
  • Provide project management to the Labelling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders
  • Lead the development of CCDS, package inserts and equivalents and their associated Patient Labelling Documents
  • Support the Head of Global Labelling in providing development and guidance to Labelling Managers and Senior Labelling Managers.


  • Proven experience in regulatory affairs with particular focus on labelling
  • Experience associated with global product labelling regulations strongly desired
  • Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies

Salary and benefits:

A competitive salary, annual bonus and wider benefits package in 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