Manager Ⅱ, CMC
Core
Develop CMC sections for PMDA consultation and Investigator's Brochures, manage IP for clinical studies in Japan, and lead responses to regulatory inquiries.
Role type
Manager II, CMC (Regulatory & IP)
Builds
Clinical study documentation and regulatory submissions for Japan
Domain
Pharmaceutical regulatory affairs and Intellectual Property management in Japan
Deliverable
client delivery
Required skills
CMC regulatory strategy, IP management, Japanese regulatory compliance, cross-functional coordination, team leadership, document review, project planning
Preferred skills
Pharmaceutics/Physical pharmacy/Analytical chemistry certification, PhD
Technologies
None stated
Responsibilities
Prepare CMC documents for PMDA and IB, coordinate IP supply and management plans, advise AST on Japanese regulatory/scientific matters, support group manager with strategy and productivity proposals, educate and motivate team members
Seniority
Manager, hands-on IC with team leadership