Regulatory Affairs Director
Remote · Amsterdam, North Holland, The Netherlands
Job Summary
Regulatory Affairs Director role leading and translating global regulatory strategy into executable plans across programs and regions. Oversee multiple regulatory programs, drive regulatory strategy execution for Expanded Access Programs, Clinical Trials, and Real-World Data, and lead a team of Regulatory Affairs professionals. Collaborate cross-functionally with Program Management, Medical Affairs, Quality Assurance, and Supply Chain; ensure regulatory input is embedded in end-to-end program delivery; drive operational excellence, standardization, and scalable processes; engage with clients and health authorities, supporting audits and inspections; manage risk, timelines, and quality while developing talent. Advanced life sciences degree and extensive regulatory affairs experience in pharma/biotech/CRO environments are required, with a track record of leading programs and teams and strong stakeholder management skills.
Required Qualifications
- Advanced degree in life sciences, pharmacy, or a related field
- Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments
- Proven experience managing multiple programs and complex regulatory portfolios
- Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments)
- Demonstrated leadership experience managing teams and developing talent
- Excellent stakeholder management and communication skills
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