- New Cairo, Cairo, Egypt
- Full-time · Manager
- 5+ years
Provide regulatory CMC leadership across complex client programs, leading CMC regulatory activities from planning through delivery.
Responsibilities
- Lead the planning and delivery of complex CMC regulatory activities across products, dossiers and markets
- Provide regulatory CMC guidance on dossier requirements, CTD/Module 3 content and Health Authority expectations
- Review CMC documentation from development, manufacturing and technical teams from a regulatory perspective
- Coordinate CMC deliverables, timelines, dependencies, risks and responses to Health Authority questions
- Lead cross-functional teams in a matrix environment, ensuring clear responsibilities, priorities and accountability
Requirements
- Degree in Pharmacy
- Degree in Chemistry
- Degree in Pharmaceutical Sciences
- Degree in Biotechnology
- Nice to have: Experience supporting proposals