EU Senior Global Regulatory Affairs Project Leader

CTC

basel, basel city, Switzerland Full-time June 21, 2026

Found Description

Main 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 subm...

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