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…