EU Regulatory Strategy Lead for Medicines

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Viatris is seeking a Regulatory Strategy Lead to drive EU regulatory strategy across a diverse medicinal product portfolio. You will lead submissions, ensure compliance, and coordinate with internal teams to align regulatory requirements with business goals.

Required: pharmacy/biotech background, 5+ years RA, fluent English, and strong interpersonal skills. The role entails close engagement with Health Authorities and partner organizations to enable timely market access.

Qualificações

• University degree in Pharmacy, Biotechnology or related pharma/medical science.
• Masters in Regulatory Affairs preferred.
• Fluent English in speaking and writing.
• 5+ years of Regulatory Affairs experience.
• Excellent interpersonal and collaboration skills.

Responsabilidades

• Lead and support regulatory strategy and execution across European markets for diverse product portfolios.
• Ensure timely approvals, license maintenance and ongoing EU compliance.
• Manage product registrations via CP, DCP, MRP, and national pathways.
• Define robust European registration strategies for successful product launches.
• Collaborate with Clinical, QA, Legal and Commercial teams to integrate regulatory requirements.

Conhecimentos

Regulatory affairs

Fluent English

Interpersonal skills

Formação académica

Pharmacy degree

Masters in RA

Descrição da oferta de emprego

Viatris is seeking a Regulatory Strategy Lead to drive EU regulatory strategy across a diverse medicinal product portfolio. You will lead submissions, ensure compliance, and coordinate with internal teams to align regulatory requirements with business goals.

Required: pharmacy/biotech background, 5+ years RA, fluent English, and strong interpersonal skills. The role entails close engagement with Health Authorities and partner organizations to enable timely market access.