• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: Mon - Fri (9am - 5pm)
• Building: Columbia University Medical Center
• Salary Range: $80,000 - $100,000

Position Summary

The Regulatory & Compliance Manager will report to the Assistant Director of Research Quality and Compliance. This role will be responsible for overseeing regulatory operations for clinical research studies within the Departments of Surgery, Otolaryngology, Neurosurgery, and Urology. The Regulatory Manager will ensure adherence to federal, state, institutional, and sponsor regulations governing human subjects research, including FDA-regulated IND/IDE studies and high-risk interventional trials.

This role will supervise the Regulatory coordinators and Technicians and provide operational leadership in regulatory start-up, maintenance, continuing review, and close-out activities. The Regulatory Manager will serve as a subject matter expert in regulatory compliance and provide guidance to investigators and research staff to ensure audit readiness and regulatory integrity across the department.

Responsibilities

Regulatory Oversight & Compliance Management:

• Oversee regulatory submissions and lifecycle management for IRB, FDA (IND/IDE), sponsor, and institutional requirements.
• Ensure timely preparation and submission of initial applications, amendments, continuing reviews, safety reports, reportable events, and study closures.
• Maintain oversight of regulatory binders and electronic regulatory systems to ensure completeness, accuracy, and audit readiness.
• Interpret and apply federal regulations (21 CFR Parts 50, 54, 56, 312, 812), ICH-GCP guidelines, and institutional policies.
• Monitor regulatory compliance across assigned studies and proactively identify compliance risks.
• Develop and implement corrective and preventive action (CAPA) plans when necessary.
• Assist in preparation for FDA, IRB, and sponsor audits and serve as a departmental representative during inspections as delegated.

Study Start-Up & Operational Support:

• Collaborate with investigators and study teams to facilitate regulatory start-up activities.
• Review protocols and consent documents for regulatory consistency and compliance prior to submission.
• Provide regulatory guidance during protocol development and feasibility discussions.
• Ensure alignment between protocol requirements, informed consent language, and institutional policy.

Personnel Supervision & Development:

• Provide direct supervision to Regulatory Coordinators, Regulatory Technicians, and compliance support staff, including hiring, onboarding, training, and performance management.
• Conduct regular one-on-one meetings, performance evaluations, and provide ongoing coaching, mentorship, and professional development opportunities.
• Oversee staff productivity and quality of work, implementing corrective actions as needed to address performance or compliance concerns.
• Establish clear expectations, goals, and accountability measures to maintain high standards of regulatory accuracy and compliance.

Policy & Process Improvement:

• Enhance and harmonize regulatory workflows and standard operating procedures (SOPs).
• Develop templates, tools, and checklists to standardize regulatory submissions and documentation.
• Identify areas for process improvement and implement efficiencies within regulatory operations.
• Support departmental training initiatives related to regulatory compliance and research quality.

Communication & Liaison Responsibilities:

• Serve as a regulatory liaison between study teams, the Institutional Review Board (IRB), Clinical Trials Office, sponsors, and regulatory bodies.
• Provide guidance to investigators and research staff on regulatory strategy and submission requirements.
• Prepare regulatory reports and documentation as required by federal agencies and institutional leadership.
• Maintain professional communication with internal and external stakeholders
• Other duties as assigned. 

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience, plus 3 years of related experience.

Preferred Qualifications

• 3-5 years of experience in clinical research regulatory affairs.
• Prior supervisory or lead experience.
• Experience supporting IND/IDE studies and high-risk interventional trials.

Other Requirements

• Demonstrated knowledge of FDA regulations, IRB processes, and ICH-GCP guidelines.
• Experience preparing for or participating in regulatory audits and inspections.
• Strong understanding of regulatory document management systems.
• Excellent verbal and written communication skills. 
• Excellent interpersonal and presentation skills. 

Equal Opportunity Employer / Disability / Veteran

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