European Regulatory Strategy Director

Viatris; Viseu; On-site; EUR 180,000 - 240,000; Full time

Job summary

Viatris is seeking a Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe to shape and lead European regulatory strategy across a diverse portfolio, developing high-performing regulatory teams and influencing critical business decisions to ensure compliant, timely delivery of medicines to patients across Europe.

For this role, we require a strong RA background, leadership experience, and fluent English, with excellent cross-functional collaboration and stakeholder management

Qualifications

• University degree in a pharma/medical science field.
• Masters in Regulatory Affairs preferred.
• Fluent English—speaking and writing.
• 15+ years RA experience, including 5+ years people management.
• Excellent interpersonal skills.

Responsibilities

• Lead a high-performing team of Regulatory professionals overseeing products developed internally or with partners, ensuring lifecycle success.
• Accountable for Regulatory activities across European markets for diverse product types with compliant delivery.
• Develop and implement European regulatory strategy aligned with Global RA objectives and stakeholder needs.
• Ensure on-time submission of post-approval lifecycle activities including renewals and variations.
• Collaborate with Clinical, QA, Legal, and Commercial teams to integrate regulatory requirements into business operations.
• Serve as liaison with EMA and national authorities, leading meetings and submissions.
• Anticipate regulatory changes, assess impact, and develop risk mitigation in partnership with the Line Manager.
• Represent Viatris in industry groups and leadership forums; guide regulatory costs and timelines.

Skills

Fluent English

RA leadership

People management

Regulatory strategy

Cross-functional collaboration

Stakeholder management

Education

University degree (Pharmacy, Biotechnology, and/or other Pharma/Medical scientific background)

Masters in RA preferred

Job description

Viatris is seeking a Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe to shape and lead European regulatory strategy across a diverse portfolio, developing high-performing regulatory teams and influencing critical business decisions to ensure compliant, timely delivery of medicines to patients across Europe.

For this role, we require a strong RA background, leadership experience, and fluent English, with excellent cross-functional collaboration and stakeholder management