Regulatory Project Manager

Job Summary

Seeking an experienced Regulatory Project Manager, this fully remote position will manage regulatory coordination for complex clinical research studies, ensuring compliance with internal and external requirements while preparing and submitting necessary documentation.

Key responsibilities

• Coordinate regulatory processes for clinical research studies within assigned units, departments, or divisions
• Review clinical research protocols and prepare all required study and regulatory documents for submission
• Collaborate with study monitors to collect and process regulatory documents in compliance with applicable laws and regulations

Required qualifications

• Experience in regulatory project management within clinical research
• Knowledge of FDA requirements and clinical trial regulations
• Ability to prepare and submit regulatory documents and applications
• Familiarity with compliance standards for federal, state, and university regulations
• Strong understanding of clinical research protocols