Head of Regulatory Affairs - Europe Cluster

Head of Regulatory Affairs - Europe Cluster

EVA Pharma

Schiphol, Netherlands

Job Summary

We are seeking a Head of Regulatory Affairs to join our team.

Lead and oversee all Regulatory Affairs activities across the European Union, ensuring regulatory compliance, lifecycle management, and strategic regulatory support for existing and new products. Drive regulatory strategy, manage the team of Regulatory Affairs, provide regulatory intelligence, support business development initiatives, and ensure successful execution of regulatory submissions and approvals across a diverse product portfolio.

Key Responsibilities

• Develop and execute EU regulatory strategies for new and existing products to ensure compliance and business objectives are met;
• Oversee all regulatory submissions, variations, renewals, extensions, and lifecycle management activities;
• Ensure compliance with EU regulatory requirements for medicinal products, and combination products;
• Lead, coach, and develop a team of Regulatory Affairs, ensuring high-quality and timely delivery of regulatory activities;
• Monitor regulatory developments, assess business impact, and provide regulatory intelligence and recommendations;
• Partner with Business Development, R&D, Quality, and external stakeholders to evaluate regulatory feasibility and support strategic projects;
• Identify and mitigate regulatory risks, providing guidance on timelines, requirements, and market entry pathways;
• Develop and deliver regulatory training programs to strengthen compliance awareness and regulatory knowledge across the organization.

Requirements

• Degree in Pharmacy, Life Sciences, Natural Sciences, or a related field;
• Minimum 10 years of Regulatory Affairs experience within the pharmaceutical industry;
• Strong knowledge of EU regulatory requirements, lifecycle management, and regulatory submission processes;
• Proven leadership experience managing and developing regulatory teams;
• Excellent strategic thinking, stakeholder management, communication, and cross-functional.