Regulatory Affairs Specialist (12 Month Fixed Term Contract)

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.

Our global portfolio includes best-in-class iconic brand-name products as well as global key brands; generics including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education outreach and better access to treatment.

For those driven to live their lives with purpose Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Do you want to own your own product portfolio and maintain marketing authorisations Would you like to correspond closely with the Danish and Icelandic health authorities while taking responsibility for regulatory activities across your markets Are you interested in developing your expertise within Regulatory Affairs and being part of a highly competent collaborative team with great team spirit If so you might be the one we are looking for.

Viatris in Denmark is part of a large global pharmaceutical organisation and represents wellknown brands within a broad portfolio including Viagra EpiPen and several other exciting products launching in the coming years.

Every day we rise to the challenge to make a difference and heres how the Regulatory Affairs Specialist role will make an impact:

• Responsibility for your own product portfolio including obtaining and maintaining Danish and Icelandic marketing authorisations (lifecycle management)

• Handling the local regulatory part of change controls and updating relevant systems within agreed timelines

• Supporting and collaborating with local QA Supply Chain Marketing Pricing Sales and Medical Information; and globally with Central Regulatory Affairs and Nordic Artwork

• Supporting tender operations and business units with timely and accurate regulatory documentation

• Corresponding with the Danish and Icelandic health authorities especially regarding applications and maintenance of marketing authorisations

• Creating abbreviated product information for your product portfolio and approving marketing materials

• Helping ensure the organisation (locally and centrally) is aware of changes in the Danish regulatory environment

About Your Skills & Experience

For this role were looking for a candidate who has an effective combination of the following qualifications skills and experiences:

• We welcome applicants without previous Regulatory Affairs experience provided you can demonstrate strong interest motivation and foundational knowledge of Regulatory Affairs

• Masters degree or equivalent in Pharmaceutical or Natural Sciences

• Ability to work independently as part of a team and crossfunctionally

• Excellent communication skills

• Work proficiency in Danish and English spoken and written

At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is but as it should be. If you would like to know more about what diversity equity and inclusion means to us please visit at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts please visit Viatris we offercompetitivesalaries benefitsandan 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.