Europe Regulatory Affairs Exec: Lifecycle & Submissions

Viatris; Lisboa; Presencial; EUR 55 000 - 85 000; Tempo integral

Resumo da oferta

Viatris, a global healthcare company, is seeking an experienced Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe. You will manage regulatory activities across Europe, coordinating with cross-functional teams, affiliates and health authorities to support registrations, lifecycle management and regulatory compliance.

The ideal candidate has a degree in life sciences, 2-3 years in regulatory affairs, and strong communication skills. English fluency is essential.

Qualificações

• 2-3 years of Regulatory Affairs experience within the pharmaceutical industry.
• Knowledge of European regulatory procedures and post-approval lifecycle management.
• Fluent English, both written and spoken.

Responsabilidades

• 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 ensure successful implementation of regulatory strategies.
• Maintain regulatory databases and documentation to ensure ongoing compliance.
• Build strong 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.

Conhecimentos

Communication skills

Stakeholder management

Fluent English

Formação académica

Degree in Pharmacy/Life Sciences

Master's in Regulatory Affairs (advantageous)

Descrição da oferta de emprego

Viatris, a global healthcare company, is seeking an experienced Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe. You will manage regulatory activities across Europe, coordinating with cross-functional teams, affiliates and health authorities to support registrations, lifecycle management and regulatory compliance.

The ideal candidate has a degree in life sciences, 2-3 years in regulatory affairs, and strong communication skills. English fluency is essential.