Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe
About this opportunity
Generics [U.K.] Ltd.
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.
This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.
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 a number of award lists that demonstrate the impact we are making.
Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe role will make an impact:
By shaping and leading European regulatory strategy across a diverse portfolio, developing high-performing regulatory teams, and influencing critical business decisions to ensure compliant, timely and successful delivery of medicines to patients across Europe.
Key responsibilities for this role include:
Key responsibilities for this role include:
Leadership & People Development
Lead a high-performing team of Regulatory professionals overseeing a portfolio of products developed internally, externally (in partnership with Viatris) or via a Third Party/ Business Development (BD) Partner, ensuring successful product lifecycle management and alignment with global business goals. Provide guidance and mentorship to ensure effective execution of regulatory strategies.
Regulatory Strategy
Accountable for all Regulatory activities impacting European markets for a diverse portfolio of medicinal products (and/or other product classifications) including Generic, Established Brand, Innovative, and Value-Added products. Oversee regulatory compliance to ensure portfolio of products meet all legal and industry standards.
Accountable for the development and implementation of European regulatory strategy that aligns with Global Regulatory Affairs objectives, partnering with Global Regulatory Affairs workstreams, maintain relations with internal/ external strategic partners through to stakeholders, provide regulatory guidance to other business functions, as well as Local European Regulatory Teams.
Portfolio Oversight
Ensure delivery of regulatory objectives through effective planning, prioritisation, and stakeholder engagement.
Partner with Local Affiliate teams to ensure CRA are appropriately educated and trained in the preparation and management of country-specific National activities.
Accountable for ensuring on-time submission of post-approval lifecycle activities, to include: Renewals, Variations (Administrative, CMC, Safety), Article 61(3) notifications and Country-specific notifications.
Cross-Functional Partnership
Work closely with internal departments such as Clinical, Quality Assurance, Legal, and Commercial teams to integrate regulatory requirements into business operations and product development. Translate complex regulatory requirements into actionable business insights for cross-functional stakeholders and influence key strategic decisions.
Liaise closely with internal functional areas to ensure alignment in all initiatives: Business Development, Regulatory CMC Sciences, Labelling, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues.
Health Authority Engagement
Serve as a primary liaison with regulatory authorities (e.g. European Medicines Agency (EMA), national competent authorities), leading meetings, preparing submissions, and facilitating approvals for new products or changes to existing products.
Governance, Compliance & Risk Management
Anticipate changes in regulations, assess their impact on operations, and develop risk mitigation strategies in collaboration with Line Manager. Investigate promptly, escalate and agree mitigation plan for any reported non-compliance issues.
Business & Industry Leadership
Be actively involved in due diligence activities including evaluation of regulatory strategy, launch timelines, evaluation of risks and regulatory costs.
Represent the company at industry associations, conferences, external working groups, and senior executive and cross-functional leadership meetings.
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:
University degree (Pharmacy, Biotechnology, and/or other Pharma/Medical scientific background)
Masters in RA is preferred
Fluent English - speaking and writing
15+ years RA Experience, including 5+ years of people management
Excellent interpersonal skills
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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
A t Viatris, we offer competitive salar ies , 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.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 112 comparable Director Regulatory Affairs roles across 44 biopharma companies.
Salary context
50 of 112 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 112 comparable roles
+ 11 more countries
Seniority mix
112 of 112 peers have a known seniority level
Therapeutic area mix
15 of 112 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Open in 3 locations
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.