EU Regulatory Affairs Director: Lead Strategy & Teams

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 150 000 - 190 000; Tempo integral

Resumo da oferta

Viatris seeks a Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe to shape regulatory strategy across Europe. You will lead a high-performing team and partner with Clinical, Quality, Legal and Commercial functions to ensure compliant, timely approvals and lifecycle management of products across diverse categories.

The role requires 15+ years of RA experience with 5+ years in people management and fluent English.

Qualificações

• University degree (Pharmacy, Biotechnology, and/or other Pharma/Medical scientific background)
• Masters in RA is preferred
• Fluent English - speaking and writing
• 15+ years RA Experience, including 5+ years of people management
• Excellent interpersonal skills

Responsabilidades

• Lead a high-performing Regulatory team overseeing a diverse European portfolio
• Define and implement European regulatory strategy aligned with Global RA objectives
• Oversee regulatory lifecycle activities and ensure timely submissions
• Collaborate with Clinical, QA, Legal and Commercial teams to integrate regulatory requirements
• Engage with EMA and national authorities; prepare submissions and facilitate approvals
• Represent the company in industry groups and cross-functional leadership meetings
• Mentor, develop and retain regulatory talent across the Europe region

Conhecimentos

Regulatory Strategy

Team Leadership

Cross-functional Collaboration

European Regulatory Affairs

Formação académica

Bachelor's degree in Pharmacy or related field

Master's in Regulatory Affairs preferred

Descrição da oferta de emprego

Viatris seeks a Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe to shape regulatory strategy across Europe. You will lead a high-performing team and partner with Clinical, Quality, Legal and Commercial functions to ensure compliant, timely approvals and lifecycle management of products across diverse categories.

The role requires 15+ years of RA experience with 5+ years in people management and fluent English.