Head of Regulatory Affairs - Europe Cluster
Full-timeIn English
About the job
Eva Pharma is seeking a Head of Regulatory Affairs for the Europe Cluster, based in Schiphol. In this role, you will lead regulatory strategy and ensure compliance across EU markets for medicinal and combination products.
What you will do
- Develop and execute EU regulatory strategies for new and existing products
- Oversee regulatory submissions, variations, renewals, extensions, and lifecycle management
- Ensure compliance with EU regulatory requirements for medicinal and combination products
- Lead, coach, and develop a regulatory affairs team
- Monitor regulatory developments and provide intelligence and recommendations
- Partner with Business Development, R&D, Quality, and external stakeholders
What you bring
- Degree in Pharmacy, Life Sciences, Natural Sciences, or related field
- Minimum 10 years of Regulatory Affairs experience in pharmaceutical industry
- Strong knowledge of EU regulatory requirements and submission processes
- Proven leadership experience managing and developing regulatory teams
- Excellent strategic thinking, stakeholder management, and communication skills
Summary by Personeel.com. The full job description and the application form are on Eva Pharma's website (apply.workable.com); Apply takes you straight there.