Regulatory Affairs Associate

1 week ago

Maidenhead, United Kingdom Planet Pharma Full time

Role: Regulatory Affairs Associate


Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.

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

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