
REGULATORY AFFAIRS MANAGER
Norway, Sweden, Denmark, Finland
Reference number: RAMN1
Genesis Global Group is currently looking for a Regulatory Affairs Manager to join a top 50 Pharmaceutical organisation based in either Norway, Sweden, Denmark or Finland with occasional travel to the other locations. Full time position with a very generous benefits package available.
The ideal candidates will have experience as a Regulatory Affairs Manager and looking to increase their exposure to the following:
-
Operational regulatory affairs activities, involving interface from local organisation to Europe RA, ensuring conformance to national and EU Drug Laws.
-
Maintaining labelling information
-
Communicating with regulatory authority and regulatory institutions if required in collaboration with Europe RA
-
Supporting Global Pharmacovigilance
-
Responsible for wholesale licenses for the local operating companies
-
Maintenance of local quality and pharmacovigilance system
-
Providing collaborative support for commercial teams
-
Responsible for product release for radiopharmaceuticals imported to region
-
ADR reporting, product complaints and product recalls on a country and regional level in cooperation with local and corporate personnel
-
Maintaining a quality system for pharmacovigilance matters
-
Acting as the NRPP (National Responsible Person Pharmacovigilance)
-
Any Nordic region languages is a bonus; English is a must
-
Candidate must be a EU citizen
In order to apply for this role, please forward your most up to date CV and quote the reference number.
TAGS: Regulatory Affairs Manager – Pharmacovigilance – ADR - Pharmaceutical