Regulatory Affairs Lead

Job Summary

Seeking a full-time remote Regulatory Affairs Lead, this role will manage regulatory activities across multiple clinical trials, ensuring compliance with protocols and guidelines while collaborating with internal teams, IRBs, and sponsors throughout the study lifecycle.

Key Responsibilities

• Proactively manage regulatory activities from feasibility through study close-out for assigned clinical trials
• Prepare and submit regulatory documents to the IRB, including initial submissions and amendments throughout the study lifecycle
• Maintain regulatory files and ensure audit readiness by keeping documentation complete and current

Required Qualifications

• Bachelor's degree in Business, Health Science, or a related field preferred
• 4-6 years of hands-on clinical research experience with a strong understanding of clinical study operations
• Demonstrated experience in clinical research regulatory affairs, including IRB submissions and management
• Familiarity with clinical research systems such as CRIO or similar platforms
• Knowledge of Good Clinical Practice (GCP), IATA, and FDA regulations