Regulatory Affairs Specialist

at  Viatris

Viatris ApS
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Do you want to own your own product portfolio and maintain marketing authorisations? – and while being responsible for your own portfolio, corresponding with the Danish and Icelandic health authorities? Are you interested in the Regulatory disciplines? Would you like to be part of a highly competent and skilled team with great team spirit? Then you might be the one we are looking for.
Viatris in Denmark is part of a large global pharmaceutical organization and represents well-known brands within a wide portfolio - like Viagra, EpiPen and several other exciting brands that will be launched in the coming years.

Every day, we rise to the challenge to make a difference and the Regulatory Affairs Manager role will make an impact as an individual contributor in the Danish Regulatory Affairs Department and is responsible for the following for the assigned product portfolio in Denmark and Iceland.

Key responsibilities for this role include:

• Responsibility for own product portfolio and obtain and maintain Danish and Icelandic marketing authorisations (life cycle management),
• Handle local regulatory part of change controls and update relevant systems in compliance with agreed timelines,
• Play a vital part in supporting and collaborating with local QA, Supply Chain, Marketing, Pricing, Sales and Medical Information and globally with Central Regulatory Affairs and Nordic Artwork,
• Support tender operations and business units by timely supply of accurate regulatory documentation and information,
• Correspond with the Danish and Icelandic health authorities primarily in connection with obtaining and maintaining marketing authorisations,
• Create abbreviated product information for assigned product portfolio and approve marketing materials,
• Assist in keeping the organisation (locally and centrally) aware of changes in the Danish regulatory environment.