Regulatory Specialist

Job Summary

A company is looking for a Regulatory Specialist (Remote, U.S.).

Key Responsibilities

• Support and maintain the eRegulatory System, including document management and compliance
• Assist with study start-up documents and ensure timely communication of essential regulatory information
• Coordinate with clinical research teams to ensure audit readiness and compliance with regulatory standards

Required Qualifications

• Experience in clinical research is strongly encouraged
• Experience with eRegulatory systems
• Proficient in Microsoft Word and Excel
• Training in Good Clinical Practice (GCP) is required
• Ability to maintain confidentiality and project a professional demeanor