The GPS Global Regulatory Affairs Life Cycle Management Team based at my clients site in Reading has a 1-year position available to build Medicinal Product capability in and outside Europe.
We are looking to hire a candidate strongly interested in Regulatory Affairs - with experience in medicinal products. You will grow and maintain major portfolio in particular for the European region, you will coordinate changes to existing products/dossiers keeping them on the market.
You will act as the point contact for our local regulatory colleagues, who manage local market and authority interactions, as well as with other technical & non-technical functions like MPD, Product Supply,QA, Marketing and manufacturing sites
Key Responsibilities:
*Build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are well reflected in projects, work processes, and in our systems.
Business Use
*Enable PHC business for the relevant portfolio within and outside Europe region by delivering to time and to GPS SOPs on agreed and aligned priority base business projects across each franchise & region, as well as on "LCM initiatives" requiring changes to existing products/dossiers.
*Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
oCoordinate with Local Regulatory Affairs for variations, renewals and answering health authority
requests.
oMaintain Global Master Dossiers a...