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