Regulatory Affairs Associate

Highly Competitive
  1. Contract
  2. Officer /Associate
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 12 Jul 2019

A leading biopharmaceutical company based in the US, is seeking a Regulatory Affairs Associate to join their Internation RA team in either Uxbridge or Cambridge, UK. The company's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. This is a 12 month contract position.

Job Responsibilities:

  • Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, including variations, PSURs/RMPs, responses to questions and renewals.
  • Preparation and/or coordination of regulatory labelling variation submissions for company marketed products in line with corporate objectives.
  • Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review and provision of accurate labelling translations.
  • Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.
  • Represent International Regulatory Affairs (Int RA) function at cross functional submission/ study management team meetings.
  • Participate in regulatory HIV team meetings, product team meetings and departmental meetings.
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  • Support the HIV Int RA team as required.

Education and/or Experience:

  • Life sciences degree
  • Relevant experience in Regulatory Affairs
  • An understanding of regulatory requirements for the EU centralised procedure
  • Experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products is desirable.
  • Experience with working with document management systems (RDMS/SIMS).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.