Senior Regulatory Affairs Officer Job – Southampton

A global healthcare company are looking for a Senior Regulatory Affairs Officer to join their team based in Southampton, UK.

Main responsibilities:

  • Gain marketing authorisations for new pharmaceutical products in the UK.
  • Maintenance of existing MAAs as required.
  • Liaise with EU Regulatory Affairs and corporate groups on regulatory issues.
  • Liaise with external regulatory authorities.
  • Draft of packaging texts, SmPCs, PILs and prescribing information.
  • Review of promotional material in accordance with the ABPI code.
  • Provide regulatory advice to other departments within the company.

Person specification:

  • Extensive experience working with pharmaceutical regulatory affairs.
  • Working knowledge of MAAs.
  • Experience of working to the ABPI code is desirable but not essential.
  • Previous experience liaising with regulatory authorities.
  • Excellent interpersonal skills.
  • Good project management skills.

Apply Now

For more information or to apply for this Senior Regulatory Affairs Officer position please contact Meera Pattni on 01438 870024 or email mpattni@ckclinical.co.uk. Please quote reference CL21837 in all correspondence.

Click here to apply online!

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