Regulatory Affairs Specialist

4 weeks ago


London, Greater London, United Kingdom Warman O'Brien Full time

Regulatory Affairs Manager

Warman O'Brien is seeking a Regulatory Affairs Manager to join their team at a globally renowned pharmaceutical business that manufactures Generic products in the UK.

This role has arisen due to an increase in workload as the team looks to expand in the UK.

The successful candidate will be a hybrid role with an expectation of 2-3 days per week in office.

Key Responsibilities

  • Compile, prepare, and submit relevant components of the dossier
  • Lead relevant agency interactions (EMA and MHRA)
  • Advise on Regulatory strategy to your line manager
  • Ensure products remain compliant with relevant legislation
  • Maintain licenses, including renewals and variations of existing licenses
  • Lead Market Authorisation Application submissions
  • Mentor junior employees accordingly

Requirements

  • 7+ years of pharmaceutical Regulatory Affairs experience
  • Experience with small molecules
  • Experience with respiratory products
  • Experience leading new submissions for Generic products (MAA, Variations, Renewals)
  • Experience maintaining Centralised European licenses
  • Experience maintaining UK licenses
  • A team player with a positive and can-do attitude

Please note, you must possess a valid right to work in the UK to be considered for this role.



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