Regulatory Affairs Labelling Manager

  • Salary: Up to £66 phr
  • REF Number: 00049665
  • Consultant:
  • Contact: 01438 842970
  • Date Published: 19.01.2021
  • Sector: Non-Specific
  • Location: Welwyn Garden City, UK Anywhere
  • Discipline: Regulatory Affairs

CK Group are recruiting for a Regulatory Affairs Labelling Manager to join a bio-pharmaceutical company working remotely on an initial 6-month contract basis. Role outside of IR35

Company: This company is one of the world's largest biotech companies which is a leading provider of both cancer treatments and in vitro diagnostics.

The Role: The main purpose of the role will be to

  • Drive and optimise the strategy for the creation and maintenance of Core Data Sheet
  • Author and maintain CDS, as well as manages the CDS processes
  • Provide regulatory strategic recommendations concerning acceptable labelling in regional markets, in collaboration with the relevant functions

Further responsibilities will include:

  • Guiding and supporting the implementation of CDS into the Local Product Labels and manages local label deviations
  • Leading/contributing to company responses on HA questions pertaining to EU and US labelling
  • Giving specific guidance on labelling regulatory issues such as legislation, guidelines, procedures to the RAFT and Project teams. Your Background: To succeed in this role, you will come from a Life Science background with considerable experience in Strategic Regulatory Labelling

For more informationor to apply for this position, please contact Hendre Moolman on 01438 842 970 or email hmoolman@ckgroup.co.uk.

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