Senior Manager, European Regulatory Policy and Intelligence

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.

Key responsibilities include:

• 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 and regulations.

About Your Skills & Experience

We are looking for a candidate who has the following qualifications, skills and experiences:

• Strong knowledge of EU market regulations and guidance governing drugs, including post marketing, and a strong understanding of regulatory requirements related to CMC aspects for drug development, product registration, and license maintenance.
• Strong knowledge of the EMA, EC, MHRA, and EU and UK legislative processes.
• Experience in European Regulatory Affairs, with a 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 skills.
• Ability to work independently.

Benefits

• Competitive salary and bonus scheme.
• Health insurance and pension.
• Career progression opportunities.
• Work life balance initiatives.

We are an Equal Opportunity Employer.