Description
My client, a German based Pharmaceutical company, is currently searching for a Regulatory Affairs Manager to join their team based in Slovakia. This will be a home based role and the successful person will ideally have strong registration, Post Approval and CMC background and be fluent in Slovakian and English.
Your background:
*You have experience with the care / Life Cycle Management of current authorizations.
*You have experience in the conduct of variation procedures and renewals.
*You are willing to take responsibility as an information officer, and possibly also as a wholesale representative.
*Have knowledge of technical and functional requirements pivotal documents (CMC member).
*Developing appropriate regulatory strategies is not a foreign word for you.
*National, MRP, DCP submissions - creation of applications for authorization and supervision of approval procedures.
*You like to communicate with customers, authorities, partners and affiliates at home and abroad.
Your profile:
*You have a scientific education.
*2+ years of regulatory experience
*You have mastered the standard Microsoft Office applications and have database experience.
*You are fluent in English and Slovakian, both spoken and written.
*Mastering other Eastern European languages is an advantage.
*You will ideally be used to working independently; but also be a team player.
For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
