Hobson Prior are looking for a Senior Regulatory Affairs Associate to join a research-based biopharmaceutical organisation to be located in either Uxbridge or Cambridge. Our client focuses on areas with unmet medical needs by discovering, developing and commercialising pioneering medicines.

Job Responsibilities:

• You will support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
• Prepare and/or coordinate regulatory labelling variation submissions for the organisations marketed products in line with corporate objectives.
• Partake in regulatory HIV team meetings, product team meetings and departmental meetings.
• 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.
• Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
• Support the HIV Int RA team as required.

Key Skills:

• Excellent oral and written English communication skills.
• Strong 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.

Requirements:

• 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).

Apply now:

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.