Regulatory Affairs Specialist

1 month ago

London, Greater London, United Kingdom ARx Recruitment Services Full time

The ARx Recruitment Services team is seeking a highly skilled Regulatory Affairs Officer to join their global pharmaceutical company based in the UK.

This role offers a unique opportunity to work closely with experienced RA professionals in a dynamic and supportive team environment.

The successful candidate will be responsible for ensuring the compliance of the company's products with regulatory requirements, supporting regulatory submissions, and coordinating site transfer projects.

Key responsibilities include:

  • Ensuring compliance of the company's products with regulatory requirements
  • Supporting the regulatory department with regulatory submissions
  • Assisting and coordinating site transfer projects
  • Preparing submissions of authorization changes and renewals
  • Liaising with regulatory bodies to facilitate the approval of submissions
  • Maintaining up-to-date records and documentation in relation to Marketing Authorizations
  • Assisting in the preparation of procedures for relevant regulatory activities
  • Complying with company policies and guidelines
  • Maintaining regulatory files/database and chronologies
  • Performing product information compliance activities
  • Checking, approving, and releasing labeling/packaging documents
  • Working closely with in-house, 3rd party designers, and contract sites for packaging artwork development and updates
  • Working with outsourced Pharmacovigilance team for new MA applications, submissions related to Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs), and renewals
  • Supporting and maintaining labeling systems, processes, and related activities
  • Identifying any compliance issues or gaps and supporting Line Manager in evaluating business impact and corrective actions
  • Gathering all required documentation for the administrative sections of CTD dossier
  • Working collaboratively across organization and contract sites

The ideal candidate will have experience with communicating with regulatory bodies at an administrative and strategic level, a good understanding of European/UK regulatory guidelines, regulations, and procedures, and an understanding of the timescales of the approval processes within regulatory bodies.

The company offers a 25K-35K salary, hybrid working (3 days at home, 2 days on site), and additional benefits.

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