Head of Regulatory Affairs - Europe Cluster at Eva Pharma

Haarlemmermeer, North Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

0.0

Posted On

11 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

EU Regulatory Strategy, Lifecycle Management, Regulatory Compliance, Regulatory Submissions, Team Leadership, Regulatory Intelligence, Stakeholder Management, Risk Mitigation, Cross-functional Collaboration, Business Development Support

Industry

Pharmaceutical Manufacturing

Description

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. 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. 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.

Responsibilities

Lead and oversee all Regulatory Affairs activities across the European Union to ensure compliance and strategic support for product portfolios. Manage the regulatory team and drive strategies for submissions, renewals, and market entry pathways.