Hobson Prior is currently recruiting for a Regulatory Associate III to be based in Cambridge on a contract basis. This is an exciting opportunity to join the International Regulatory Affairs team at a thriving research-based pharmaceutical company.
- Responsible to support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure.
- Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.
- Preparation and/or coordination of regulatory labelling variation submissions for the organisations 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.
- Represent the International Regulatory Affairs function at cross functional submission/ study management team meetings.
- Partake 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.
- Strong oral and written English communication skills.
- Excellent planning and organizational skills with the ability to work simultaneously on a number of projects with tight timelines.
- Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
- Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
- Life sciences degree.
- Relevant experience in Regulatory Affairs.
- An understanding of regulatory requirements for the EU centralised procedure.
- Previous experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products is desirable.
- Previous experience with working with document management systems (RDMS / SIMS).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.