Hobson Prior are currently seeking for a Senior Regulatory Affairs Associate to join a research-based biopharmaceutical company. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them.
- Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure.
- 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.
- Preparation and/or coordination of regulatory labelling variation submissions for Gilead’s marketed products in line with corporate objectives.
- Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.
- Represent the International Regulatory Affairs function at cross functional submission/ study management team meetings.
- Contribute 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.
- Ability to facilitate/impact and influence effective interactions and discussions.
- Able to effectively interact to information gather and effectively drive projects through to completion to tight timelines.
- Life sciences degree.
- Relevant experience in Regulatory Affairs.
- Knowledge of regulatory requirements for the EU centralised procedure.
- A good scientific background and understanding.
- Experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products is desirable.
- Prior 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.