Senior Director CMC Technical Authoring – Global Technical Operations
Core
Lead the authoring of post-approval regulatory submissions for biologics and drive the transformation of regulatory operations using generative AI, automation, and structured content management.
Role type
Senior Director, Regulatory Strategy & AI Transformation
Builds
AI-enabled regulatory submission processes and digital regulatory capabilities
Domain
Biopharmaceuticals / Regulatory Affairs / Generative AI
Deliverable
production ML models
Required skills
Regulatory strategy, AI solution implementation, organizational change management, program management, lifecycle management, health authority interaction
Preferred skills
PhD or PharmD, experience across multiple therapeutic areas, knowledge of global regulations
Technologies
Generative AI, structured content management, regulatory copilots, document intelligence
Responsibilities
Create a 3–5 year roadmap for independent AI-enabled authoring; Implement generative AI solutions for drafting and lifecycle documentation; Partner with Digital and IT to deploy regulatory copilots; Lead organizational change and capability building; Benchmark external industry practices.
Seniority
Senior Director, strategic leadership