Regulatory Affairs Associate

  • Salary: Competitive
  • REF Number: 00050279
  • Consultant: Mary Bolt
  • Contact: 01246 457729
  • Date Published: 01.04.2021
  • Sector:
  • Location: West London,
  • Discipline:

CK Group are recruiting for a Regulatory Affairs Associate to join a global manufacturer in the pharmaceutical industry at their site based in West London on a permanent basis.

The Company:

Our client is a leading manufacture of pharmaceuticalproducts with a presence across the world.

Location:

This Regulatory Affairs Associate role is located in West London, close to the M25, M4 and Heathrow airport. .

Regulatory Affairs Associate Role:

Your main dutieswill be to:

  • Compile and submit appropriate MA applications in applicable countries to support drug product manufacturing transfers and compile and submit appropriate variations to support drug product manufacturing transfers, API source changes, batch release site amendments and other variations such as, labeling changes etc.
  • Work with Artwork and labeling teams for artwork changes and implementation (serialization projects, MA transfers, etc.)and work with cross functional team and contract manufacturers to ensure successful and timely transfer of products to new CMO.
  • Be responsible for overall document management and regulatory data consolidation for all products into information software.

Your Background:

The ideal candidate for this role will have/be:

  • Educated to degree level or above in life science or a related field with Regulatory Affairs experience in a pharmaceutical, GMP environment.
  • Practical experience of compilation of regulatory submissions for new registrations, variations, renewals and updates to prescribers information and labelling in EU and international markets (excluding USA) and practical knowledge of European and other regulatory requirements relating to variations of all types.
  • Practical knowledge of the ICH Common Technical Document and knowledge of ASEAN CTD as well as sterile product manufacturing and control would be advantageous.

For more information or to apply for this Regulatory Affairs Associate position, please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk quoting job ref 50279

It is essential that applicants hold entitlement to work in the UK.

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