Regulatory Affairs Professional

2 weeks ago


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

Warman O'Brien is seeking a seasoned Regulatory Affairs Manager to lead regulatory efforts for a renowned pharmaceutical business in the UK.

This role has been created due to an increase in workload as the team looks to expand its presence in the UK market.

The ideal candidate will have a hybrid work arrangement with 2-3 days of office time per week.

Key Responsibilities
  • Compile and submit relevant dossier components to regulatory authorities.
  • Lead interactions with key agencies, including the EMA and MHRA.
  • Provide strategic guidance on regulatory matters to senior management.
  • Ensure compliance with relevant legislation and regulations.
  • Maintain licenses through renewals and variations.
  • Oversee Market Authorization Application submissions.
Requirements
  • Minimum 7 years of experience in pharmaceutical Regulatory Affairs.
  • Proven expertise in small molecule and respiratory product regulation.
  • Leadership experience in new submissions for generic products (MAA, Variations, Renewals).
  • Centralized European license maintenance experience.
  • UK license maintenance experience.
  • A collaborative team player with a positive attitude.

As a note, candidates must possess a valid right to work in the UK to be considered for this position.

We estimate a salary of £80,000 - £100,000 per annum, commensurate with experience, for this opportunity.



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