Regulatory Coordinator I

Responsibilities

• Coordinate all aspects of advanced therapy protocol submissions for research projects.
• Prepare and submit necessary documentation to the IRB, PRMC/CTRC, IBC, and Cellular Therapy Program committees.
• Maintain regulatory approvals, including annual IRB renewals, FDA annual reports for IND studies, and adverse event reporting.
• Ensure timely submission of manufacturing updates, product deviations, and unanticipated problems.
• Coordinate study monitoring and auditing visits, including preparations for FDA, FACT, and sponsor inspections.
• Serve as a primary regulatory liaison and resource for the Cell and Gene Therapy research teams.
• Attend and present at program meetings and maintain accurate study listings for investigators.

Requirements

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

Preferred Qualifications

• Knowledge of FDA cellular therapy regulations and gene therapy guidelines.
• 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.

About the Company

Columbia University Medical Center is a leading academic medical center dedicated to groundbreaking research and life-saving patient treatments. Our Cell Engineering & Therapy team works at the forefront of innovation, translating advanced research into clinical realities.