Regulatory Coordinator I - Cell Engineering & Therapy

Columbia University Irving Medical Center; New York (NY); On-site; USD 68,000 - 75,000; Full time

Job summary

Columbia University Irving Medical Center is hiring a Cell and Gene Therapy Regulatory Coordinator. This full-time position involves ensuring regulatory compliance for advanced therapy trial submissions and facilitating patient access to innovative treatments.

The candidate will coordinate protocol submissions, maintain audit-ready files, and support research teams in navigating regulatory requirements. An educational background and strong organization skills are essential.

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.

Responsibilities

• Coordinates all aspects of advanced therapy protocol submission for research projects.
• Ensures regulatory approvals for all required components of trials are obtained.
• Coordinates assigned study monitoring and auditing visits for protocols.

Skills

Organizational skills

Analytical skills

Problem-solving skills

Interpersonal skills

Proficiency with Microsoft Office

Education

Bachelor's degree or equivalent

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Teams

Microsoft OneDrive

Microsoft SharePoint

Smartsheet

Job description

Grade 103

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

• Coordinates all aspects of advanced therapy protocol submission for research projects, preparing and submitting all necessary documents to the IRB, PRMC/Cell Therapy Research Council, IBC, and Cellular Therapy Program committees; serves as the 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, including annual IRB renewal submissions, internal cell & gene therapy reports, FDA annual reports for IND studies, adverse event reporting, manufacturing updates, product deviations, and official reporting of unanticipated problems to appropriate regulatory bodies.
• Coordinates assigned study monitoring and auditing visits for cell and gene therapy protocols, assisting in preparations for routine monitoring, FDA inspections, FACT audits, sponsor audits, and coordinating with cell therapy laboratories and manufacturers for compliance visits.
• Serves as an integral part of cellular and gene therapy research teams, attending and presenting at Cell and Gene Therapy Program meetings and disease-specific CAR-T team meetings, maintaining and disseminating accurate listings of active and potential studies to investigators, and providing resources for current regulatory information and FACT immuno-effector cell standard 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.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.