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Regulatory Affairs Associate

4 months ago

Maidenhead, United Kingdom Planet Pharma Full time

Role: Regulatory Affairs Associate

Location: Maidenhead / M4 corridor.

Salary: Very competitive salary on offer


Planet Pharma are supporting a leading large global pharma company with the search for a new Regulatory Affairs Associate to join them during an exciting period of growth Perfect for a junior regulatory professional with 6-24 months regulatory 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
  • Interact with Health Authorities


Requirements:

  • 6-24+ months experience in Regulatory Affairs
  • Experience with submissions to the MHRA is essential
  • Bachelor’s degree or equivalent in a relevant scientific subject