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Regulatory Affairs Manager, Labelling

Regulatory Affairs Manager, 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:

    23395_1620891373

  • Published:

    4 months ago

  • Expiry date:

    2021-06-12

  • 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.

Responsibilities:

  • 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.

Requirements:

  • 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