Regulatory Affairs Professional

20 hours ago


Hertfordshire, United Kingdom X4 Life Sciences Full time

We are seeking a talented Regulatory Affairs Professional to join our team at X4 Life Sciences. The successful candidate can expect a salary of $90,000 - $115,000 per annum, based on their qualifications and experience.

Key Responsibilities:

  • This role involves overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).
  • The successful candidate will assist in preparing, compiling, and publishing documentation for the Common Technical Document (CTD) dossier.
  • Implementing and communicating MA changes to relevant stakeholders is a critical component of this role.
  • Collaboration with internal teams, external vendors, and contract sites is essential for developing and updating packaging artwork.
  • The Regulatory Affairs Professional will create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and company approval systems.
  • Liaising with various departments, clients, and regulatory authorities is vital for effective communication.
  • Maintaining regulatory files, databases, and document chronologies, and tracking changes in documents submitted to agencies or partners is another key responsibility.
  • Supporting New Product Development and Lifecycle Management projects is also an essential part of this role.
  • The Regulatory Affairs Professional will lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.


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