Senior Manager, CMC Dossier Management
Core
Develop and oversee CMC strategic project plans to support regulatory deliverables (INDs/IMPDs, Marketing Applications) by creating content plans, source document maps, and timelines.
Role type
Senior Manager, CMC Dossier Management
Builds
Regulatory submission dossiers and project management frameworks for CMC teams
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC functional experience (chemistry, analytical, formulation), regulatory submission planning, source document mapping, project management, risk analysis, root cause analysis, cross-functional coordination, process improvement
Preferred skills
Late-stage development experience, laboratory-based CMC function background
Technologies
Standardized project management tools
Responsibilities
Create and maintain content plans, source document maps, rosters, and timelines; monitor submission progress against deadlines; identify and analyze business risks; conduct root cause analyses; coordinate diverse teams; establish and maintain stakeholder networks; assess process effectiveness and recommend improvements.
Seniority
Senior, hands-on IC