European Regulatory Affairs Manager – Strategy & Submissions

Viatris; Lisboa; Presencial; EUR 80 000 - 110 000; Tempo integral

Resumo da oferta

Viatris is seeking a Regulatory Affairs Manager – Central Regulatory Affairs (Europe) to lead regulatory strategy for a diverse medicinal portfolio across European markets. You will manage submissions via CP, DCP, MRP, and national pathways and partner with internal teams to ensure timely approvals and compliance.

You will collaborate with Clinical, Quality Assurance, Legal, and Commercial functions, liaise with Health Authorities, and drive risk mitigation and regulatory excellence across the

Qualificações

• Bachelor's degree in Pharmacy or related field is required or equivalent.
• Masters in Regulatory Affairs is preferred but not mandatory.
• Fluent English—spoken and written—is essential.

Responsabilidades

• Lead and implement European regulatory strategy across a diverse portfolio.
• Manage registration processes via CP, DCP, MRP, and national routes.
• Collaborate with Clinical, QA, Legal, and Commercial teams to align requirements.
• Engage with Health Authorities (EMA, national authorities) to facilitate approvals.

Conhecimentos

Regulatory affairs

English (fluent)

Interpersonal skills

Collaboration

Formação académica

Bachelor's degree in Pharmacy/related

Master's in Regulatory Affairs (preferred)

Descrição da oferta de emprego

Viatris is seeking a Regulatory Affairs Manager – Central Regulatory Affairs (Europe) to lead regulatory strategy for a diverse medicinal portfolio across European markets. You will manage submissions via CP, DCP, MRP, and national pathways and partner with internal teams to ensure timely approvals and compliance.

You will collaborate with Clinical, Quality Assurance, Legal, and Commercial functions, liaise with Health Authorities, and drive risk mitigation and regulatory excellence across the