EU Senior Global Regulatory Affairs Project Leader (m/f/d
Job in
4123, Allschwil, Kanton Basel-Landschaft, Switzerland
Listed on 2026-08-01
Listing for:
Flexsis
Full Time
position Listed on 2026-08-01
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
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
- 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
Position Requirements
10+ Years
work experience
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