Hobson Prior currently have an opportunity for a Regulatory Affairs Support to join a leading pharmaceutical organisation focused on saving lives all over the world by discovering, developing and offering pioneering products and services. This position will be on a contract basis located in Brussels.

Job Responsibilities:

• Assists in compilation and submission of regulatory documents to the local regulatory authorities and - as applicable - to the European Medicines Agency related to new applications, variations, renewals, PSURs etc.
• Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
• Ensures that regulatory databases and systems are kept updated and complete.
• Partakes in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Partakes in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
• Manages the planning and submission activities for PSURs, in cooperation with regional and global teams.
• In connection with submission of MA applications, variations, renewals and PSURs etc assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
• Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.
• Any other assigned duties.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.