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Regulatory Affairs Manager UK Affiliate - West Sussex

  • Location

    West Sussex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    26759_1641484998

  • Published:

    19 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Affairs Manager UK Affiliate - West Sussex

A Pharmaceutical company with products in Immunology, Hematology, and Albumin are seeking a Regulatory Affairs Manager within their UK and Ireland Affiliate

Responsibilities:

  • Prepare, organise and coordinate data / documents to meet national submission requirements for new licences, licence renewals, variations, PSURs and DSURs.
  • Prepare and maintain national labelling (SmPC, PIL and labels)
  • Maintain national distribution licences and participate in GDP inspections as required.
  • To liaise with national functions (medical, marketing, safety, quality, customer services) as necessary to support the national business needs

Requirements:

  • Experience of UK and EU Regulatory Affairs.
  • Experience of working closely with logistics, medical and marketing functions
  • Experience of biological medicines and medical devices
  • Experience of liaising with MHRA and other healthcare authorities

Salary and benefits:

A highly competitive salary, annual bonus and wider benefits scheme is on offer

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