Regulatory Life Cycle Management Scientist

3 weeks ago


Reading, Berkshire, United Kingdom CK Group Full time
CK Group are recruiting for a Regulatory Life Cycle Management Scientist to join a biopharmaceutical company who are based in Reading on a contract basis for 12 months.

Company:

Out client is a global consumer healthcare business with well known household brands.

Location:

The role is based in Reading.

Role:

  • Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
  • Coordinate with Local Regulatory Affairs for variations, renewals and answering health authority requests.
  • Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio.
  • Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system.
  • Ensure that the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
  • Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.

Your Background:

  • Educated to ideally Masters’ degree level in pharmacy, engineering, chemistry or a similar field.
  • Regulatory affairs experience, preferably in consumer health and preferably across multiple regulatory classification areas.
  • Experience of dossier maintenance and product change management as well as working with complex Regulatory databases.
  • Excellent attention to detail, good communication and presentation skills.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 103371 in all correspondence.



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