Senior Director, Regulatory Affairs CMC
Core
Lead strategic, tactical, and operational regulatory CMC activities for clinical trials, market registrations, and post-approval submissions for small molecule therapeutics.
Role type
Senior Director, Regulatory Affairs CMC
Builds
Regulatory dossiers and submissions for investigational, registration, and post-approval lifecycle stages
Domain
Biopharmaceuticals / Small molecule therapeutics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic regulatory CMC leadership, CMC dossier content development, Health Authority interaction, global regulatory requirements knowledge, risk mitigation, change control management
Preferred skills
Advanced degree in life sciences, experience with small molecule product lifecycle management
Technologies
Regulatory guidelines, Health Authority meeting platforms
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, identify and mitigate regulatory CMC risks, monitor global regulatory trends
Seniority
Senior Director, strategic leadership with hands-on execution