Senior Director, Regulatory Affairs CMC
Core
Senior Director leading strategic, tactical, and operational Regulatory CMC activities for clinical trials, market registrations, and post-approval submissions.
Role type
Senior Director, Regulatory Affairs CMC
Builds
Regulatory CMC dossiers and strategies for small molecule products
Domain
Biopharmaceuticals / Small molecule development
Required skills
Regulatory CMC strategy, Health Authority interaction, global regulatory guidelines, dossier content development, risk mitigation, change control management
Preferred skills
Advanced degree in life sciences, small molecule lifecycle management experience
Technologies
Regulatory frameworks, Health Authority submission systems
Responsibilities
Develop and lead execution of regulatory CMC strategies; guide team on dossier content conformance; represent function in Health Authority meetings; provide global input on quality-related activities; monitor and communicate global regulatory trends
Seniority
Senior Director, strategic leadership with hands-on execution