Regulatory Analyst - 137899

The Department of Medicine is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego and employs 486+ full-time salaried faculty members and 100+ academic appointees. Staff personnel include 600+ staff in 9 bargaining units, students, and volunteers. There are 250 clinical faculty practicing at multiple sites and hospitals.

Cardiovascular clinical research represents one of the largest and most complex research portfolios within the department, often encompassing more than 100 active studies at any given time. These projects span a wide spectrum-from early-phase device innovation and interventional trials to heart failure therapeutics, imaging, electrophysiology, prevention, gene therapy, and long-term outcomes research. The breadth and volume of this portfolio require not only robust operational infrastructure but also specialized compliance and regulatory oversight, led in part by a dedicated compliance analyst/regulatory analyst. This role is critical in ensuring adherence to FDA, ICH-GCP, IRB, and institutional requirements; monitoring regulatory submissions and approvals; reviewing study documentation for accuracy and readiness; and proactively identifying areas of risk or noncompliance before they impact research activities. With more than 100 active projects moving simultaneously, the expertise of a compliance/regulatory analyst is essential to maintaining the integrity, safety, and audit-readiness of the entire cardiovascular research enterprise.

Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and / or action. Serves as a technical expert and advisor to department head.

• Nine years of related experience, education/training, OR an Bachelor's degree in related area plus five years of related experience/training.

• Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.

• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.

• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

• Strong proficiency in public speaking, and writing.

• Relevant compliance certification (if applicable) preferred.

• Employment is subject to a criminal background check.