Senior Regulatory Affairs Associate

Job description

Senior Regulatory Affairs Associate

The Regulatory Affairs Associate is responsible for the registration document(s) procurement, preparation and coordination. You will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.

You will also be responsible for the below duties;

  • Registration document(s) procurement, preparation, coordination submission and archival
  • Coordinates legalization and delivery of registration documents following the instructions provided in the request.
  • Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
  • Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.


The next Regulatory Affairs Associate should have a 3rd level degree in Science/Engineering with 2 years’ experience in a Pharma or Biopharma environment. You should also demonstrate basic knowledge regarding CMC sections of a Marketing Application.


If you’re looking to work with a world leading Biotechnology company that offers flexible working options, get in touch now!


If you are interested in discussing this further, please contact Ryan for a confidential discussion at OR 014744661


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