Regulatory Affairs Director
Remote · United Kingdom or United States
Job Summary
Regulatory Affairs Director responsible for translating global regulatory strategy into execution across programs and regions; oversee multiple regulatory programs ensuring timely delivery, quality, and client satisfaction; lead and develop Regulatory Affairs Managers and senior team members; collaborate cross-functionally with Program Management, Medical Affairs, Quality Assurance, and Supply Chain; drive standardization and scalability of regulatory processes; engage with clients and Health Authorities to support regulatory interactions, inspections, and risk management.
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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