Regulatory Affairs Director

  • Salary: £750 per day LTD
  • REF Number: 00049124
  • Consultant: Julie Marshall
  • Contact: 01438 842964
  • Date Published: 21.10.2020
  • Sector:
  • Location: Remote Working, Home/Field Based
  • Discipline:

CK Group are recruiting for a Regulatory Affairs Director to join a company in the Pharmaceutical industry on a contract basis for 12 months. This position is remote for UK-based contractors only.

Rate: Up to £750 per day LTD (Experience dependent)

Regulatory Affairs Director Role:

  • Lead submission and approval of oncology biosimilars in EU/US and ROW
  • Lead health authority interactions along with technical experts to facilitate approval
  • Lead and responsible for planning, developing and managing the biosimilar regulatory dossier for global submission.
  • Lead and responsible for post approval submission activities including product maintenance, supply and compliance activities

Your Background:

  • At least a Bachelor's degree in a scientific or related field
  • Extensive regulatory affairs experience in the pharmaceutical industry including product approval/launch.
  • Oncology and biologics/antibody experience is essential
  • Specific US regulatory approvals is essential
  • Strong project management experience, capable of managing a team across the globe

Company: Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Apply: For more information, please contact Andy or Lucy on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Pleasequote reference 49124.

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