Regulatory Affairs Director – Central Europe

About the role

Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Director – Central Europe role will make an impact. By shaping and leading European regulatory strategy across a diverse portfolio, developing high‑performing regulatory teams, and influencing critical business decisions, you will ensure compliant, timely and successful delivery of medicines to patients across Europe.

Key responsibilities

• Lead a high‑performing team of regulatory professionals, providing guidance and mentorship to execute regulatory strategies for internally and externally developed products.
• Develop and implement European regulatory strategy aligned with global objectives, overseeing compliance for generic, established brand, innovative and value‑added products.
• Ensure on‑time submission of post‑approval lifecycle activities such as renewals, variations, Article 61(3) notifications and country‑specific filings.
• Collaborate with Clinical, Quality Assurance, Legal, Commercial and other functions to integrate regulatory requirements into product development and business operations.
• Act as primary liaison with the European Medicines Agency and national competent authorities, leading meetings, preparing submissions and facilitating approvals.
• Anticipate regulatory changes, assess impact, and develop risk‑mitigation strategies while supporting due‑diligence and business‑development activities.

Required profile

• University degree in Pharmacy, Biotechnology or related scientific field; Master’s in Regulatory Affairs preferred.
• Fluent English (spoken and written) with 15+ years of regulatory affairs experience, including at least 5 years of people‑management responsibility.
• Proven ability to lead cross‑functional teams and influence senior business decisions.
• Strong interpersonal and communication skills.

Required skills

• Regulatory affairs expertise covering strategy, compliance and lifecycle management.
• Experience interacting with the European Medicines Agency and national competent authorities.
• Knowledge of European regulatory frameworks for generic, innovative and value‑added products.