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Regulatory Affairs Officer

The company comprises of Clinical, Pharmacovigilance, Quality, Marketing and Regulatory Affairs departments. They are now recruiting a Regulatory Affairs Officer for the Global Regulatory Affairs (GRA) team to be located in Sweden to support the rapidly growing Nordics team and European business. 

In this position, you are responsible for the critical Regulatory Affairs work in the Nordic countries.

With a very exciting pipeline with many launches in the next couple of years there is a need for a clear regulatory strategy and execution.

You report directly to Director of Global Regulatory Affairs based in Dublin and you have dotted line to GM Nordics for the day-to-day business. You will be a member of the Nordic leadership team.

It is an excellent opportunity for an ambitious person to make a difference and who wants to pursue a career within the Group.

Key accountabilities:

- Part of the Global Regulatory Affairs team and providing Regulatory Affairs Lead support for the Nordic region projects.

- Supports and or prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with Nordic and Corporate needs and timelines.

- Preparation and responsibility for Nordic region regulatory affairs lifecycle maintenance (variations, renewals…) labelling updates, pricing & reimbursement/market access and managing local translations.

- Actively participates and employs effective communication practices with Nordic Region management and Global Regulatory Affairs and other internal functions as needed customers.

- Flexibility to provides regulatory affairs support on non-Nordic region projects on occasion.

Experience:

- 2-3 years human pharmaceutical regulatory experience.

- Experience with Nordic region regulatory affairs.

- Experience of EU DCP, MRP and National Nordic MAAs.

- Project management experience - an advantage.

- Experience of Women’s and/or Men’s healthcare – an advantage

Place of work: 

Malmö

For further information:

Ingmar Karlsson, +46 709 13 13 31 alt. ingmar@mandly.se