Assistant Director, Regulatory Affairs - Hybrid

🇺🇸 Hybrid - Orange, CA 🕑 Full-Time 💰 $108K - $205K 💻 Compliance 🗓️ April 19th, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring an Assistant Director, Regulatory Affairs to manage and supervise the Regulatory Affairs Unit within the Stern Center for Cancer Clinical Trials & Research. The role involves overseeing regulatory submissions for clinical research protocols, ensuring compliance with institutional and federal requirements, managing staff, and liaising with regulatory agencies to facilitate timely protocol activation.

Highlights

Direct and supervise the Regulatory Affairs Unit responsible for protocol submissions to regulatory committees.
Manage a team of 14 regulatory affairs coordinators handling pre-award and maintenance tasks.
Ensure protocols meet regulatory requirements and achieve activation targets according to NCI and institutional standards.
Serve as liaison with federal regulators such as FDA and OHRP and represent UC Irvine at regional meetings.
Develop and implement policies and procedures for compliance with federal and state regulations.
Required skills include advanced knowledge of FDA regulations, GCP guidelines, clinical protocol design, and technical writing.
Experience with clinical research oversight, oncology clinical research, and managing compliance review boards.
Proficiency with Microsoft Office suite; experience with OnCore CTMS preferred.
Bachelor’s degree and 7-9 years of regulatory oversight experience in academic or research settings required.
Salary range from $108,100 to $204,900 per year, with comprehensive benefits.