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Senior Labelling Lead

Hertfordshire   •  Permanent, Full time

CK Group are recruiting for a Senior Labelling Lead to join a global Pharmaceuticals. Flexible home working is available and offices are based in Hatfield.

Senior Labelling Lead Role:
As a Senior Labelling Lead you will be creating, verifying, maintaining and/or justifying the Safety and Regulatory compliant product information (PI) texts (Labelling) and as required, associated activities, for, but not limited to, central regulatory affairs (CRA) managed group procedures.

Key duties will include:

  • Awareness of and adherence with labelling requirements including, but not limited to relevant internal and external legislation, regulations standard operating procedures, guidance and templates etc.
  • Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader and CMC data.
  • Authoring of the SmPC , confirming compliance with mandated safety triggers, brand leader, CMC and relevant labelling requirements
  • Maintaining company core data sheets
  • Support Brand Leader monitoring process

Your Background:
As a Senior Labelling Lead you will require:

  • A relevant Life Science degree.
  • Proven extensive experience of Regulatory Affairs labelling.
  • Proficiency in speaking, comprehending, reading and writing English skills
  • Previous experience of document management system is advantageous

Quote job ref 51665.
It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Ashleigh Williamson
  • Phone: 0) 1438 870 022
  • Reference: 51665
  • Posted: 14th September 2021
  • Expires: 12th October 2021

CK Group

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