Location: New York, NY
Cap-Exempt H-1B Position — No lottery required
- Job Type: Officer of Administration - Regular/Temporary: Regular - Hours Per Week: 35 - Salary Range: $68,000.00 - $75,000.00 *The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.* Position Summary The Cell and Gene Therapy Regulatory Coordinator ensures comprehensive regulatory compliance for investigator-initiated trials (IITs) and industry-sponsored trials (ISTs) by coordinating protocol submissions to IRB, PRMC/Research Council, IBC, and cellular therapy committees while maintaining audit-ready files for FDA, FACT, and sponsor inspections. The position facilitates patient access to innovative CAR-T, gene therapy, and cellular immunotherapy treatments by ensuring timely regulatory approvals and coordinating with external sponsors for compliance visits. As the primary regulatory liaison, the coordinator supports research teams by participating in program meetings and providing current FDA guidance updates to facilitate protocol development. This role strategically balances rigorous safety oversight with efficient advancement of therapy, ensuring regulatory excellence that enables the translation of groundbreaking research into life-saving patient treatments. Responsibilities Responsibilities include, but are not limited to: - Coordinates all aspects of advanced therapy protocol submission for research projects. - Prepares and submits all necessary documents to the Institutional Review Board (IRB), Protocol Review Monitoring Committee (PRMC)/Cell Therapy Research Council (CTRC), Institutional Biosafety Committee (IBC), and Cellular Therapy Program committees. - Primary point of contact for cell & gene therapy submissions. - Ensures regulatory approvals for