EU Senior Global Regulatory Affairs Project Leader (m/f/d)

Role Overview

The EU Senior Global Regulatory Affairs (RA) Project Leader provides strategic regulatory leadership for the development, approval, and life-cycle management of innovative medicinal products across Europe. The role partners closely with global cross-functional teams and acts as a key interface with the European Medicines Agency (EMA) and EU National Competent Authorities to enable timely, compliant regulatory pathways.

Key Responsibilities

• Define and execute EU regulatory strategies in alignment with global development plans
• Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities
• Lead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages
• Oversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life-cycle updates
• Ensure EU labeling compliance and alignment with the Company Core Data Sheet
• Represent Regulatory Affairs on cross-functional project and governance teams
• Maintain regulatory intelligence and assess impact of new guidance and regulations
• Contribute regulatory expertise to due diligence and business development activities
• Develop and lead global regulatory strategies and Regulatory Functional Plans
• Coordinate global submission planning and execution
• Own creation and maintenance of the global Company Core Data Sheet
• Lead regulatory sub-teams and ensure delivery of regulatory milestones
• Support affiliates and partners with global regulatory strategy and execution

Qualifications & Experience

• Master’s degree (or equivalent) in Life Sciences or related discipline
• 8+ years of Regulatory Affairs experience within pharma or biotech
• Expert knowledge of EU, ICH, and global regulatory frameworks
• Extensive experience working with EMA and EU National Competent Authorities
• Strong understanding of clinical development and regulatory life-cycle activities
• Excellent communication, stakeholder management, and project leadership skills
• Fluent English (written and spoken)

Interested? Reach out to me directly!