EU Senior Global Reg Affairs Project Leader (m/f/d)

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.

Every day, we rise to the challenge to make a difference and here’s how the EU Senior Global Reg Affairs Project Leader (m/f/d) role will make an impact:

• →Define and execute EU regulatory strategies in alignment with global development plans
• →Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities
• →Lead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages
• →Oversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life-cycle updates
• →Ensure EU labeling compliance and alignment with the Company Core Data Sheet
• →Represent Regulatory Affairs on cross-functional project and governance teams
• →Maintain regulatory intelligence and assess impact of new guidance and regulations
• →Contribute regulatory expertise to due diligence and business development activities
• →Develop and lead global regulatory strategies and Regulatory Functional Plans
• →Coordinate global submission planning and execution
• →Own creation and maintenance of the global Company Core Data Sheet
• →Lead regulatory sub-teams and ensure delivery of regulatory milestones
• →Support affiliates and partners with global regulatory strategy and execution

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

• Master’s degree (or equivalent) in Life Sciences or related discipline
• 8+ years of Regulatory Affairs experience within pharma or biotech
• Expert knowledge of EU, ICH, and global regulatory frameworks
• Extensive experience working with EMA and EU National Competent Authorities
• Strong understanding of clinical development and regulatory life-cycle activities
• Excellent communication, stakeholder management, and project leadership skills
• Fluent English (written and spoken)

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.

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

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.