Head of Regulatory Affairs - Europe Cluster
4w1 month agoEVA Pharma
NL · Full-time · €130,000 – €170,000
About this role
EVA Pharma, a leading pharmaceutical company recognized as a best place to work, is seeking a Head of Regulatory Affairs to lead all regulatory activities across the European Union. This role is central to our mission of empowering the fight for health and well-being as a fundamental human right.
You will develop and execute EU regulatory strategies for new and existing products, ensuring compliance and business objectives are met. Day-to-day responsibilities include overseeing all regulatory submissions, variations, renewals, extensions, and lifecycle management activities for a diverse product portfolio.
Leading, coaching, and developing a team of Regulatory Affairs professionals, you will ensure high-quality and timely delivery of regulatory activities. You will also monitor regulatory developments, assess business impact, and provide regulatory intelligence and recommendations to the organization.
This role offers the opportunity to partner with Business Development, R&D, Quality, and external stakeholders to evaluate regulatory feasibility and support strategic projects. You will identify and mitigate regulatory risks while providing guidance on timelines, requirements, and market entry pathways across the EU.
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, and cross-functional collaboration skills.
- Experience with regulatory feasibility assessments and market entry pathways for the EU.
- Ability to provide regulatory intelligence and assess business impact of regulatory developments.
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.
Benefits
- Recognized and certified as a best place to work.
- Supportive and innovative environment for team members.
- Opportunity to lead regulatory strategy across the European Union.
- Role with significant cross-functional partnership and strategic impact.