Director, Regulatory Affairs CMC
Core
Leads global regulatory CMC strategies for small molecule investigational and commercial products, overseeing Health Authority engagement and submission execution.
Role type
Director, Regulatory CMC (Strategy & Leadership)
Builds
Global regulatory submissions and strategies for small molecule portfolios
Domain
Biotechnology / Small Molecule Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global CMC regulatory strategy, Health Authority negotiation, team leadership, risk assessment, digital regulatory content management, AI-enabled process oversight, cross-functional stakeholder influence
Preferred skills
Advanced degree (M.S., Pharm.D., Ph.D.), experience with structured content and data governance, AI tool implementation in regulated environments
Technologies
AI-enabled authoring and review tools, digital regulatory platforms, knowledge management systems
Responsibilities
Develop and execute global CMC regulatory strategies, oversee preparation and approval of CMC content for submissions, lead Health Authority interactions, coach and develop regulatory staff, identify and mitigate regulatory risks, drive process improvements using digital and AI capabilities
Seniority
Director, strategic leadership with people management