Associate Director, Global Regulatory Sciences - CMC
Core
Develop global regulatory CMC strategies and execute them for small molecules, biologics, cell therapy, and device products across the product lifecycle.
Role type
Senior IC regulatory sciences director (CMC)
Builds
Regulatory submissions (CTA, NDA, post-approval) and compliance documentation for global markets
Domain
Pharmaceutical industry, CMC regulatory strategy
Required skills
CMC regulatory strategy, global regulations interpretation, manufacturing change control assessment, Health Authority interface, project management, risk mitigation, technical team leadership
Preferred skills
Small molecules expertise, biotechnology knowledge, cell therapy experience, advanced therapies knowledge
Technologies
Regulatory Information Management systems, electronic dossier creation tools
Responsibilities
Lead matrix teams for lifecycle management projects, provide strategic guidance on regulatory requirements, manage complex CMC submissions, interface with Health Authorities, assess manufacturing change controls, interpret global regulations, mitigate drug supply issues, ensure regulatory compliance
Seniority
Senior, hands-on IC with team leadership