EU Regulatory Affairs Leader — Strategy, Submissions, & Leadership

Eva Pharma; Netherlands; Remote; EUR 120,000 - 180,000; Full time

Job summary

Eva Pharma in the Netherlands is seeking a Head of Regulatory Affairs to lead EU regulatory strategy, ensure compliance across medicinal products, and manage lifecycle activities for a diverse portfolio.

You will coach and develop a Regulatory Affairs team, monitor changes in regulation, and partner with Business Development, R&D, Quality, and external stakeholders to drive timely submissions and successful approvals.

Qualifications

• Degree in Pharmacy, Life Sciences, Natural Sciences, or 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 collaboration.

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.

Skills

Leadership

Strategic thinking

Stakeholder management

Communication

Cross-functional collaboration

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Team leadership

Training & development

Education

Pharmacy degree

Life Sciences degree

Job description

Eva Pharma in the Netherlands is seeking a Head of Regulatory Affairs to lead EU regulatory strategy, ensure compliance across medicinal products, and manage lifecycle activities for a diverse portfolio.

You will coach and develop a Regulatory Affairs team, monitor changes in regulation, and partner with Business Development, R&D, Quality, and external stakeholders to drive timely submissions and successful approvals.