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

About the role

Viatris is hiring an experienced Regulatory Affairs professional to manage regulatory activities for a portfolio of pharmaceutical products across Europe. The role works with cross-functional teams, affiliate partners and health authorities to support product registrations, lifecycle management and regulatory compliance.

Key responsibilities

• Manage regulatory activities for a portfolio of pharmaceutical products across Europe.
• Prepare and submit regulatory applications, variations, renewals and other lifecycle management activities.
• Support new product registrations through European and national regulatory procedures.
• Collaborate with European affiliate teams to implement regulatory strategies.
• Maintain regulatory databases and documentation to ensure ongoing compliance.
• Build relationships with internal stakeholders and external business partners.
• Support interactions with regulatory authorities and contribute to responses to health authority queries.
• Monitor regulatory developments and assess their impact on the product portfolio.

Required profile

• Degree in Pharmacy, Biotechnology, Life Sciences or a related scientific discipline.
• 2-3 years of Regulatory Affairs experience in the pharmaceutical industry.
• Knowledge of European regulatory procedures and post-approval lifecycle management.
• A Master's in Regulatory Affairs is advantageous.
• Fluent written and spoken English.

Required skills

• Strong communication and stakeholder management skills.
• Excellent organisational skills and attention to detail.