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

About the role

Viatris, a global healthcare company, is hiring a Regulatory Affairs Manager for its Central Regulatory Affairs (CRA) function covering Europe. The role leads and supports regulatory strategy and execution across European markets for a diverse portfolio of medicinal products, including generics, established brands, innovative and value-added products, and ensures timely approvals, licence maintenance and ongoing compliance with EU and national requirements.

Key responsibilities

• Develop and implement European regulatory strategy aligned with Global Regulatory Affairs objectives, partner with Global workstreams and give regulatory guidance to other business functions and local European teams.
• Manage a portfolio of products developed internally, externally or through third-party BD partners.
• Prepare and submit on time post-approval lifecycle activities such as renewals, variations (administrative, CMC, safety), Article 61(3) notifications and country-specific notifications.
• Oversee procedures and lead new product registrations through the Centralised, Decentralised and Mutual Recognition Procedures and national pathways, acting as the primary regional expert and defining European registration strategies.
• Partner with local affiliate teams to deliver agreed filing strategies for nationally approved products.
• Work with Clinical, Quality Assurance, Legal, Commercial, Regulatory CMC Sciences, Labelling, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues, and liaise with third-party BD partners.
• Engage with health authorities such as the EMA and national competent authorities, preparing submissions and building relationships to secure optimal outcomes.
• Assess regulation changes, support risk mitigation strategies and handle reported non-compliance issues.
• Mentor and train the team in specialist areas.

Required profile

• University degree in Pharmacy, Biotechnology or another pharma/medical science background.
• Master's in Regulatory Affairs preferred.
• 5+ years of regulatory affairs experience.
• Fluent English, speaking and writing.
• Excellent interpersonal skills.