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Regulatory Affairs Associate Director, Global Labelling

Regulatory Affairs Associate Director, Global Labelling

  • Location

    Oxfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    22394_1618233311

  • Published:

    4 months ago

  • Expiry date:

    2021-05-12

  • 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.

Responsibilities:

  • 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.

Requirements:

  • 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