Regulatory Specialist

Job Summary

A company is looking for a Regulatory Specialist to support clinical research operations remotely.

Key Responsibilities

• Maintain audit-ready Investigator Site Files (ISF) and ensure timely regulatory document submissions
• Ensure compliance with ICH-GCP, FDA regulations, and prepare for audits and inspections
• Coordinate with cross-functional teams to support regulatory alignment and documentation needs

Required Qualifications

• Bachelor's degree preferred, ideally in a science or healthcare-related field
• 1-3 years of clinical research regulatory experience
• Strong understanding of ICH-GCP guidelines and experience with IRB submissions
• Experience with CTMS/eRegulatory systems, preferably CRIO
• Strong organizational skills and ability to manage multiple protocols and deadlines