Regulatory Affairs Manager

Mylan AB

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.
 

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 

We are looking for a Regulatory Affairs Manager to join our team in Solna - Sweden — a workplace recognised as a Great Place to Work, where collaboration, trust, and inclusion are at the heart of everything we do.

In this role, you will take responsibility for the regulatory lifecycle of a broad product portfolio for Sweden and work closely with engaged colleagues across functions.

You will have the opportunity to make a real impact while being supported in an environment where people feel valued, respected, and empowered to grow.

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Manager role will make an impact: 

• Manage regulatory activities for your own product portfolio.
• Prepare and maintain Product Information, artwork approval and Module 1 documentation
• Work with National, MRP/DCP and Centralised procedures.
• Develop and implement regulatory strategies for variations, renewals, new applications, and post-approval activities.
• Work closely with central regulatory and coordinate at national/Nordic level, i.e. regulatory submissions, safety updates, and change controls in close collaboration with internal stakeholders.

About Your Skills & Experience 

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

• Bachelor’s degree in Pharmaceutical, Life or Natural Sciences (or equivalent).
• 3–5 years relevant of experience in Regulatory Affairs from a Pharma Company.
• Experience of development and translation of Product Information and Artwork in Swedish.
• Comfortable working independently and collaboratively in cross-functional teams.
• Strong communication skills and a structured working style.
• Fluent in Swedish and English.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. 

Benefits at 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. Some of our benefits include the following on top of a competitive salary: 

• A Great Place to Work–certified environment built on trust, inclusion, and teamwork.
• Engaged colleagues and supportive leadership.
• Flexibility and opportunities for personal and professional growth.
• The chance to contribute to patient safety and access to medicines.

  

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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion  

Sustainability 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 https://www.viatris.com/en/about-us/corporate-responsibility  

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.