Regulatory Coordinator I - Cell Engineering & Therapy

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 all required components of cell and gene therapy research/clinical trials are obtained and maintained.
  • Annual IRB renewal submissions and internal cell & gene therapy reports.
  • FDA annual reports for IND studies and cell & gene therapy adverse event reporting.
  • Timely submission of all required documents, including manufacturing updates and product deviations.
  • Official reporting of Unanticipated Problems and cellular therapy-specific adverse events to appropriate regulatory bodies.
• Coordinates assigned study monitoring and auditing visits for cell and gene therapy protocols.
  • Assists in preparations for routine monitoring, FDA inspections, FACT audits, and sponsor audits for advanced therapy clinical trials
  • Coordinates with cell therapy laboratories and cell & gene therapy manufacturers for regulatory compliance visits
• Serves as an integral part of cellular and gene therapy research teams.
  • Attend and present at Cell and Gene Therapy Program meetings and disease-specific CAR-T team meetings
  • Maintains and disseminates accurate listings of active and potential cellular/gene therapy studies to participating investigators
  • Serves as a resource for current regulatory information/statuses for FACT Immune Effector Cell Standards updates.
• Performs other related duties and participates in special projects as assigned.

Minimum Qualifications

• Bachelor's Degree or equivalent in education and experience.
• HIPAA, Good Clinical Practice (GCP), and Conflict of Interest (COI) training certification required upon hire.
• Excellent organizational, analytical, and problem-solving skills.
• Excellent interpersonal and organizational skills.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, OneDrive, and SharePoint.

Preferred Qualifications

• Knowledge of FDA cellular therapy regulations and gene therapy guidelines preferred
• Two years of related regulatory experience
• Experience with cellular therapy protocols, gene therapy studies, or advanced therapeutic regulatory requirements
• Familiarity with Columbia University research and clinical systems
• Proficiency with Smartsheet