Regulatory Manager - Cardiology

Responsibilities

• Provide operational and strategic oversight of regulatory compliance and quality assurance for cardiology clinical research portfolios.
• Oversee the regulatory lifecycle, including protocol start-up, maintenance, and closure activities.
• Supervise regulatory staff, including recruitment, onboarding, training, and performance management.
• Implement quality control mechanisms to ensure audit readiness and consistency of regulatory documentation.
• Manage preparation for sponsor monitoring visits, internal audits, and federal inspections.
• Develop and revise regulatory workflows, SOPs, and documentation standards to improve efficiency.
• Serve as the primary escalation point for high-risk regulatory issues and compliance concerns.
• Ensure strict adherence to HIPAA, ICH-GCP, FDA regulations, and institutional policies.

Requirements

• Bachelor's Degree or equivalent in education and experience.
• At least four years of progressive experience in clinical research regulatory or quality assurance roles.
• Advanced knowledge of ICH-GCP, FDA regulations (21 CFR), OHRP guidance, and IRB processes.
• Demonstrated experience in audit preparation and compliance risk mitigation.
• Proficiency in Microsoft Office applications and ability to learn research-specific systems (IRB platforms, EMR).
• Strong leadership, organizational, and decision-making skills.

Preferred Qualifications

• Previous experience in a supervisory or formal team leadership role.
• Professional certification such as ACRP, SOCRA, RAPS, or PRIM&R CIP.
• Experience managing Sponsor-Investigator submissions.
• Background working within academic medical center research environments.
• Experience developing compliance dashboards and regulatory reporting frameworks.

About the Company

Columbia University is a world-class research institution dedicated to advancing knowledge and improving lives through groundbreaking medical research and education.