Manager, Regulatory Operations

Job Summary

A company is looking for a Manager, Regulatory Operations (Remote).

Key Responsibilities

• Lead and develop a team to ensure timely and compliant regulatory submissions
• Oversee daily regulatory operations and maintain relationships with IRBs and Sponsors/CROs
• Monitor key metrics and drive process improvements in collaboration with Quality Assurance

Required Qualifications

• Bachelor's degree or equivalent experience in lieu of degree
• 5+ years of experience in a regulatory research setting
• Proficiency with Microsoft Office and Regulatory Data Tracking/Document Management Systems
• Advanced knowledge of IRB, FDA, and IBC requirements
• Experience in audit/inspection readiness