Regulatory CMC Manager
Core
Manages day-to-day Chemistry, Manufacturing, and Controls (CMC) regulatory activities for development and marketed projects to ensure compliance with domestic and international regulations.
Role type
Senior Regulatory CMC Manager
Builds
Regulatory submissions (eCTD) and technical documentation for FDA and international authorities
Domain
Biopharmaceuticals / Neurological and psychiatric disorders
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, FDA regulations (cGMP), eCTD/electronic filing, change control management, cross-functional leadership, project management, external contract services management, regulatory analysis
Preferred skills
Experience with electronic document management systems, ability to work independently
Technologies
eCTD, electronic document management systems
Responsibilities
Maintain CMC aspects of US regulatory filings and clinical trial applications; assist in writing and editing regulatory submissions; research and analyze current regulations; provide CMC regulatory support to QA, QC, and Manufacturing teams; communicate with regulatory authorities; participate in project team meetings
Seniority
Senior, hands-on IC with strategic oversight
