Regulatory Affairs Associate
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.
- 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).
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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.
€0.00 - €40000.00 per annum
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