• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $100,000 - $110,000

Position Summary

The Regulatory Manager will be responsible for the overall regulatory functions performed across all disease groups within the Clinical Protocol & Data Management (CPDM) Office. The position is responsible for the day-to-day operations of a core of research personnel dedicated to the regulatory aspects of human subject's research/clinical trial execution. The position demands mastery level understanding of local, federal, and international regulations. An advanced level understanding of regulatory submission processes, inclusive but not limited to those of OHRP, FDA, ICH-GCP, local/central IRBs, and external industry partners/Sponsors is expected. Trial types within the office include retrospective/prospective research with protocols that are industry/externally Sponsored, National Cancer Institute (NCI) (i.e., SWOG, NRG, Alliance) Sponsored, and Investigator-Sponsored IITs. The Regulatory Manager reports directly to the Assistant Director for Regulatory Affairs, Quality and Cancer Center Committees.

This position is located at 400 Kelby St. Fort Lee, NJ.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Leadership & Staff Management

• Directs, coordinates, and evaluates the work of Regulatory Coordinators across the CPDM.
• Determines workloads and protocol assignments based on complexity, timelines, and staff capacity.
• Posts and justifies new or replacement positions; screens applicants and conducts interviews.
• Oversee onboarding, training (protocol-specific, university, and departmental), and performance management.
• Conducts annual performance reviews, establishes measurable goals, and recommends salary adjustments.
• Creates and promotes professional development opportunities internally and externally.
• Liaises with the HICCC HR representative for all HR-related functions.

Regulatory Oversight & Compliance

• Develops, implements, and monitors quality control mechanisms to ensure accuracy and consistency in regulatory submissions.
• Oversees preparation and maintenance of regulatory documentation for new and ongoing studies.
• Supports Sponsor-Investigator–held IND/IDE submissions, renewals, and safety reporting.
• Ensures readiness for internal, sponsor, and FDA audits and monitoring visits.
• Promotes adherence to institutional, state, and federal regulations (21 CFR, ICH GCP, and institutional SOPs).
• Maintains effective communication and positive relationships with sponsors, CROs, and regulatory agencies.

Operational Excellence & Strategic Development

• Assesses trial complexity, workload, and resource allocation to ensure safety and compliance.
• Participates in collaborative research meetings to provide regulatory and protocol management expertise.
• Develops and implements new processes and tools that streamline operations and enhance efficiency.
• Contributes to the development and execution of departmental SOPs and standardized templates.
• Collaborates with CPDM leadership to promote cross-coverage, ensure continuity, and strengthen departmental communication.
• Assists in departmental reporting, metrics development, and continuous quality improvement initiatives.
  Cross-Functional Collaboration
• Partners with investigators, clinical teams, and administrative staff to support successful protocol activation and maintenance.
• Attends and contributes to internal and external meetings and research-related committees.
• Serves as a regulatory subject matter expert, advising on policy interpretation and compliance matters.

Other Duties

• Performs additional responsibilities as assigned

Minimum Qualifications

• Bachelor’s degree or equivalent plus four years of related experience.

Preferred Qualifications

• At least one year of supervisory experience. Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
• Excellent interpersonal and organizational skills.
• Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
• Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.

Equal Opportunity Employer / Disability / Veteran

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