European Regulatory Affairs Lead - Central Strategy

Viatris Inc.; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

Viatris Inc. seeks a Regulatory Affairs Manager to lead and execute European regulatory strategies for a diverse portfolio of medicines, including generics and branded products.

You will partner with Clinical, Quality, Legal, and Commercial teams to ensure compliant submissions and timely market access across EU member states. The role requires a university degree in a pharma field, 5+ years in RA, fluent English, and strong stakeholder management.

Qualifications

• University degree in Pharmacy, Biotechnology, or related field.
• Masters in Regulatory Affairs preferred.
• Fluent English (speaking and writing).
• 5+ years RA experience.
• Excellent interpersonal skills.

Responsibilities

• Lead regulatory strategy and ensure timely approvals across Europe.
• Manage registrations via CP, DCP, MRP and National pathways.
• Collaborate with Clinical, QA, Legal, and Commercial teams.
• Engage with EMA and national authorities for submissions.
• Assess regulatory changes and mitigate non-compliance risks.

Skills

Fluent English

Interpersonal skills

Regulatory affairs

Education

Bachelor degree in Pharmacy/ Biotechnology/ related

Masters in Regulatory Affairs preferred

Job description

Viatris Inc. seeks a Regulatory Affairs Manager to lead and execute European regulatory strategies for a diverse portfolio of medicines, including generics and branded products.

You will partner with Clinical, Quality, Legal, and Commercial teams to ensure compliant submissions and timely market access across EU member states. The role requires a university degree in a pharma field, 5+ years in RA, fluent English, and strong stakeholder management.