Regulatory Affairs Manager, Labelling

Regulatory Affairs Manager, 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 Manager, Labelling

A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Manager, Labelling to join their Operations team. This role will have responsibility for preparing labelling documents for submission and implementation globally.


  • Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
  • Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
  • Responsible for proofreading and departmental QC work, including during the Linguistic Review stages for EU language translations.
  • Participate in the maintenance of Labelling documents with regard to CMC and technical changes in alignment with requirements and in support of the Labelling content leads.


  • Proven experience in regulatory affairs with particular focus on labelling
  • Experience associated with global product labelling regulations strongly desired
  • B.S/B.A. (or equivalent in industry related experience)
  • 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