Manager, Regulatory Affairs CMC
Core
Manager supporting CMC regulatory filings, lifecycle management, and health authority interactions for lentiviral vector (LVV) manufacturing and cell therapy products.
Role type
Manager, Regulatory Affairs CMC
Builds
Regulatory submissions (INDs, CTAs, BLAs, MAAs) and lifecycle documentation for LVV and cell therapy programs
Domain
Biopharmaceuticals / Cell and Gene Therapy / Viral Vector Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory requirements knowledge, ICH guidelines, lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), analytical characterization, regulatory submission preparation, health authority interaction, change control assessment, risk management
Preferred skills
Cell and gene therapy / CAR-T / ATMP program experience, viral vector manufacturing and characterization, replication-competent lentivirus (RCL) safety assessments, contract manufacturing organization (CMO) experience
Technologies
None explicitly listed
Responsibilities
Support preparation and submission of CMC regulatory filings; Contribute to Module 3 (CMC) content development; Partner with cross-functional teams on LVV process development and manufacturing; Assess change controls for regulatory impact; Support health authority interactions and inspection readiness; Maintain accurate regulatory records
Seniority
Manager, hands-on IC