Regulatory Affairs Support Officer

Real Staffing
12 Aug 2017
15 Aug 2017
Contract Type
Full Time
An extremely important business partner to retail pharmacies across the UK & Ireland are recruiting for a Regulatory Affairs Support Officer to join their team at their headquarters in Scotland. They have recently expanded internationally, importing pharmaceuticals from the EU and exporting pharmaceuticals to the Middle East, North Africa and the European Union. Your skills will be utilised when providing submissions in the UK to MHRA and overseeing license and variation applications. In addition to this, you'll have the ability to work on labelling and Parallel Import License Applications (PLPI). Responsibilities for this role include: Coordinating and preparing regulatory submissions Developing regulatory strategy for MAAs in line with current regulatory requirements Liaising with health authorities to ensure regulatory compliance Life-cycle maintenance (variations, renewals, etc.) Preparing Summary of Characteristics (SPC) and Patient Information Leaflets (PILs) for new or changed files Parallel Import Licensing Advising manufacturers on regulatory requirements Requirements for this role are: 2+ years within Regulatory Affairs Experience with submissions to UK, Ireland & EU regulatory bodies Previous experience with Parallel Import is desirable, however not essential Knowledge of the life-cycle and maintenance of product information Experience in registration of medicinal products in the EMEA and other international markets Knowledge in registration process and assessment of non-medicinal products Sthree UK is acting as an Employment Agency in relation to this vacancy.