EU Regulatory Affairs Director — Strategy & High-Impact Leadership

Viatris; Lisboa; On-site; EUR 120,000 - 160,000; Full time

Job summary

Viatris is seeking a Regulatory Affairs Director for Central Regulatory Affairs in Europe with a strong leadership background. The role shapes European regulatory strategy, leads teams, and partners with multiple departments to deliver compliant medicines across Europe.

The ideal candidate has a pharmacy/biotech background, 15+ years in regulatory affairs, and 5+ years of people management. A global, inclusive environment and competitive compensation are offered.

Qualifications

• University degree in Pharmacy, Biotechnology, or other pharma/medical science field.
• Masters in Regulatory Affairs is preferred.
• Fluent English in speaking and writing; 15+ years RA experience, including 5+ years people management.

Responsibilities

• Lead a high-performing Regulatory team across Europe, including internal and external collaboration.
• Develop and implement European regulatory strategy aligned with Global Regulatory Affairs objectives.
• Oversee regulatory activities for a diverse product portfolio and ensure compliance with legal/industry standards.
• Partner with Local Affiliate teams to educate and prepare for country-specific activities and submissions.
• Collaborate with Clinical, Quality Assurance, Legal and Commercial teams to integrate regulatory requirements into business operations.
• Engage with regulatory authorities (EMA / national authorities) and lead submissions and approvals.
• Manage governance, risk, and due diligence related to regulatory strategy and costs.
• Represent Viatris in industry groups, conferences, and leadership meetings.

Skills

Fluent English

People management

Leadership

Cross-functional collaboration

Education

University degree in Pharmacy/Biology/Pharma

Masters in Regulatory Affairs (preferred)

Job description

Viatris is seeking a Regulatory Affairs Director for Central Regulatory Affairs in Europe with a strong leadership background. The role shapes European regulatory strategy, leads teams, and partners with multiple departments to deliver compliant medicines across Europe.

The ideal candidate has a pharmacy/biotech background, 15+ years in regulatory affairs, and 5+ years of people management. A global, inclusive environment and competitive compensation are offered.