Regulatory Compliance Manager

2 days ago


Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Description

We are looking for a highly motivated Regulatory Affairs Specialist to join our team at X4 Life Sciences.

In this role, you will be responsible for overseeing the lifecycle maintenance of registered Marketing Authorizations (MAs), including preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.

You will also assist in implementing and communicating MA changes to relevant stakeholders, ensuring effective management of compliance activities.

A competitive salary of $90,000 - $120,000 per year is offered, depending on experience, as well as opportunities for career growth in a dynamic and innovative company.

Responsibilities
  1. Develop and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and company approval systems.
  2. Liaise with various departments, clients, and regulatory authorities to ensure effective communication.
  3. Maintain regulatory files, databases, and document chronologies, and track changes in documents submitted to agencies or partners.
  4. Support New Product Development and Lifecycle Management projects.


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