Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe

Viatris; Lisboa; Presencial; EUR 150.000 - 190.000; Jornada completa

Descripción de la vacante

Viatris seeks a Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe to shape regulatory strategy across Europe. You will lead a high-performing team and partner with Clinical, Quality, Legal and Commercial functions to ensure compliant, timely approvals and lifecycle management of products across diverse categories.

The role requires 15+ years of RA experience with 5+ years in people management and fluent English.

Formación

• 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

Responsabilidades

• Lead a high-performing Regulatory team overseeing a diverse European portfolio
• Define and implement European regulatory strategy aligned with Global RA objectives
• Oversee regulatory lifecycle activities and ensure timely submissions
• Collaborate with Clinical, QA, Legal and Commercial teams to integrate regulatory requirements
• Engage with EMA and national authorities; prepare submissions and facilitate approvals
• Represent the company in industry groups and cross-functional leadership meetings
• Mentor, develop and retain regulatory talent across the Europe region

Conocimientos

Regulatory Strategy

Team Leadership

Cross-functional Collaboration

European Regulatory Affairs

Educación

Bachelor's degree in Pharmacy or related field

Master's in Regulatory Affairs preferred

Descripción del empleo

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:

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, elevate 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

• 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.

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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.