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.
KEY RESPONSIBILITIES FOR OUR NEW REGULAROTY AFFARIS MANAGER
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.
YOUR PROFILE
Viatris is a large global pharmaceutical company, and some tasks will be performed across countries. This means that you will have internal contacts both domestically but also in the European region, which requires a fluent English and a flair for manage own projects. For these projects and tasks, a structured mindset is needed and preferably shown in previous similar jobs.
Your experience could come from a global company, as we are too – so you know how to work with colleagues from other functions and countries.
Master’s degree or equivalent in Pharmaceutical or Natural sciences
Experience or specific interest in Regulatory Affairs
Able to work both individually, in a team and cross-functionally
Excellent communication skills
Work proficiency in both Danish and English language is a must; spoken and in writing.
We strongly believe that our employees strive to follow our Expectations – Own it, Stay Agile, Be real and Take Pride. We are Stronger Together.
ABOUT VIATRIS
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.
Globally Viatris is close to 37.000 colleagues represented in more than 165 countries.
In Denmark, Viatris is located in Ballerup in a new and nice office building. We are 45 engaged and motivated colleagues, and we work closely with our Norwegian colleagues too.
At Viatris, we offer competitive salaries, benefits, flexible working arrangement and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.