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Regulatory Affairs

Regulatory Affairs Manager (maternity cover)

Details

  • Full-time fixed term contract position – up to 12 months
  • Office based in Surrey with WFH 2-3 days a week
  • Competitive package
  • Managerial title but NOT currently line managing anyone
  • Global pharma company

The Role

  • Preparation and/or review of regulatory applications including change of ownership, variations, renewals, new Marketing Authorisation applications in EU and UK territories.
  • Support regulatory approval and maintenance of products in global locations in conjunction with local partners or licence holders.
  • Prepare and/or review product information text.
  • Implementation of product artwork.
  • Review of product regulatory compliance.
  • File regulatory documentation internally, maintain comprehensive product files.
  • Advise on Change Requests for Regulatory function.
  • Initiate Change Requests for regulatory changes.
  • Communicate regulatory changes to contract manufacturers and other interested parties both prior to and following update of the Marketing Authorisation.

Full job description available on application

The Candidate

  • Minimum 2 years Regulatory Affairs (Pharmaceutical medicines). UK/European experience essential, multinational experience desirable.
  • Medical Devices Regulations experience or a strong interest to work in devices might be advantageous but this role predominantly deals with medicines.
  • UK/European experience essential, multinational experience desirable
  • Only candidates with existing right to work in the UK/EU will be considered

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