Regulatory Affairs Specialist

3 weeks ago


Slough, Slough, United Kingdom Pro4orm People Limited Full time

About the Role:

We are seeking a highly experienced Senior Regulatory Affairs Manager to join our growing team at Pro4orm People Limited. This exciting opportunity will appeal to those with a strong background in EU regulatory affairs and a passion for delivering high-quality submissions and approvals.

Responsibilities:

  • Prepare and submit variation applications, renewals, and PSURs in line with specified timelines.
  • Manage and submit National, Mutual Recognition, and Decentralised Procedure applications in the region.
  • Prepare and maintain product information (SmPC/PIL) and manage regulatory activities related to the UK and EU markets.
  • Record data in relevant regulatory databases and maintain a regulatory archive.
  • Prepare regular reports for regulatory and management purposes and support various business functions.
  • Contribute to the strategic development of the regulatory function and ensure compliance with procedures.

Requirements:

  • Life Sciences degree or equivalent.
  • In-depth understanding and experience of EU regulatory requirements, including marketing authorisation submissions and maintenance activities.
  • Experience working in a UK affiliate is a requirement, with experience in other non-EU markets in the region an advantage.
  • Proven success in the timely management of regulatory approval procedures and ability to work to deadlines.
  • Excellent verbal and written communication skills and ability to work in a multicultural environment.


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