Senior Manager, European Regulatory Policy and Intelligence

McDermott Laboratories Limited

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

The Global Regulatory Policy and Intelligence (GRPI) team serves as strategic advisors to regulatory teams and other business units by monitoring, interpreting, and shaping developments in regulatory policy, as well as steering engagement with health authorities and industry associations externally and subject matter experts internally to advance important positions and initiatives aligned with Viatris’ portfolio priorities.

The European Regulatory Policy & Intelligence role will be a strong subject matter expert on European regulatory policy and procedure, shaping strategic responses to evolving legislative, regulatory, and trends in the external environment. This role is responsible for delivering timely, actionable regulatory intelligence and leading cross‑functional efforts to influence, anticipate, and adapt to changes in the European regulatory landscape affecting our portfolio.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, European Regulatory Policy & Intelligence role will make an impact:

• Monitor, assess, and interpret evolving European regulations, guidelines, legislative proposals, implementation frameworks, and agency outputs.

• Lead the development of regular intelligence reports and strategic briefings in support of larger coordinated engagement strategies affecting the development of positions on key regional regulatory policy topics.

• Represent the organization in EU-based, regulatory-focused trade associations, working groups, consortiums, and scientific/regulatory policy forums.

• Ensure effective implementation of changes related to scientific and regulatory guidance across the portfolio. Lead the review, communication of impact, and requisite implementation of revised/newly issued guidance/regulations. 

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:

• Strong knowledge of EU market regulations and guidance governing drugs including post-marketing, with a strong understanding of regulatory requirements related to CMC aspects for drug development, product registration, and license maintenance. Relatedly, the candidate should posses a strong knowledge of the EMA, EC, MHRA, and EU and UK legislative processes.

• Experience in European Regulatory Affairs, with a strong preference for demonstrated success in cross-functional engagement

• Proven ability to analyze complex regulatory and policy issues and translate them into clear business recommendations.

• Established communication skills and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders. Exceptional written communication.

• Ability to work independently.

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:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

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.