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Regulatory Affairs Officer

3 months ago

Uxbridge, United Kingdom Planet Pharma Full time

Role: Regulatory Affairs Officer

Location: Uxbridge, UK - Hybrid working schedule (2 days WFH)

Salary: Very competitive salary on offer


Our client is a large global pharmaceutical company and they are seeking a Regulatory Affairs Officer to join them during an exciting period of growth This candidate must have 6-12 months regulatory experience and will have the opportunity to broaden their knowledge and experience.


Role summary:

Manage the operational and technical aspects of regulatory affairs for the UK, Ireland and Maltese marketing affiliates.


Responsibilities:

  • Implement Regulatory Plan in-line with affiliate business plans
  • Ensure Submissions and Approvals for Regulatory Applications in a timely manor.
  • Prepare and support new MAAs
  • Assist with the maintenance for MAAs


Requirements:

  • 6-12+ months experience in Regulatory Affairs
  • Experience with submissions to the MHRA is essential
  • Experience with RIMS and TRACKWISE
  • Experience with UK