Manager, Regulatory Affairs
Core
Manage global CMC regulatory implementation for cell therapy products in oncology and autoimmune disease development.
Role type
Manager, Regulatory Affairs (CMC focus)
Builds
Regulatory submissions (IND, CTA, DMF, AR/DSUR) and change amendments for cell therapies
Domain
Biotechnology / Cell Therapy / Oncology / Autoimmune
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory CMC strategy, FDA/ex-US submission management, IND/CTA/DMF/AR/DSUR knowledge, GxP compliance, change control management, database maintenance, global regulatory guidance interpretation
Preferred skills
Advanced degree in life sciences/pharmacy, QA/analytical testing/manufacturing/research experience
Technologies
Microsoft Office, electronic CTD systems
Responsibilities
Drive global regulatory timelines for CMC functions, prepare and file CMC submissions and amendments, assist in developing briefing books for FDA/EMA meetings, review CMC/clinical/nonclinical documentation for GxP compliance, maintain regulatory databases, communicate regulatory changes to cross-functional teams
Seniority
Manager, hands-on IC