Senior Regulatory Affairs Coordinator - Europe

Viatris; Lisboa; Presencial; EUR 36 000 - 54 000; Tempo integral

Resumo da oferta

Viatris, a global healthcare company, is seeking a (Senior) Regulatory Affairs Administrator - Central Regulatory Affairs, Europe, to support regulatory activities across Europe and ensure compliance with European and local requirements.

The role focuses on post-approval submissions, maintaining regulatory information management systems, and collaborating with local affiliate teams to achieve timely regulatory objectives.

Qualificações

• Previous administrative experience, ideally within pharmaceuticals, healthcare, life sciences, or a regulated environment.
• Strong interest in Regulatory Affairs and the pharmaceutical industry.
• Excellent organisational skills and attention to detail.
• Strong communication and stakeholder management skills.
• Fluent English, both written and spoken.

Responsabilidades

• Support regulatory activities across a portfolio of pharmaceutical products throughout Europe.
• Assist with post-approval submissions including variations, renewals, and regulatory notifications.
• Coordinate administrative and compliance activities to support the maintenance of marketing authorisations.
• Maintain and update Regulatory Information Management (RIM) systems and databases.
• Work closely with local affiliate teams on regulatory and operational activities.
• Support regulatory fee processing, purchase orders, and other administrative tasks.
• Collaborate with cross-functional teams to ensure timely delivery of regulatory objectives

Conhecimentos

Administrative experience

Fluent English

Communication

Stakeholder management

Organisational skills

Interest in Regulatory Affairs

Ferramentas

RIM systems

Descrição da oferta de emprego

Viatris, a global healthcare company, is seeking a (Senior) Regulatory Affairs Administrator - Central Regulatory Affairs, Europe, to support regulatory activities across Europe and ensure compliance with European and local requirements.

The role focuses on post-approval submissions, maintaining regulatory information management systems, and collaborating with local affiliate teams to achieve timely regulatory objectives.