Shaojun Zhu

23-170 CHS

Mr. Zhu is Associate Adjunct Professor and Director of Regulatory Affairs of Nuclear Medicine within the Department of Molecular and Medical Pharmacology. He received his Bachelor and Master’s degrees in Biochemistry and Molecular Biology from Nankai University, China. Later he received Master’s degree in regulatory science from University of Southern California (USC), and received Regulatory Affair Certification (RAC) credential from Regulatory Affairs Professional Society (RAPS). Prior to his academic appointment with UCLA, he served as regulatory affair director and science liaison at UCLA Department of Molecular and Medical Pharmacology.

Research Description:

Mr. Zhu’s work focuses regulatory science on radiopharmaceuticals for both diagnostics and therapeutics. His work includes radiopharmaceutical research and development, regulatory strategy framework, regulatory risk assessment and management, regulatory pathway planning and nonclinical radiopharmaceutical safety assessment (pharmacology and toxicology) for first-in-human use. He oversees regulatory interactions with the Food and Drug Administration (FDA) and Center for Medicare & Medicaid Services (CMS) for clinical trial clearance, radiopharmaceutical approval and reimbursement. He also advises and manages the Biomedical Cyclotron PET drug current Good Manufacturing Practice (cGMP) compliance program and Nuclear Medicine Clinic Good Clinical Practice (GCP) compliance. His work resulted in successful Investigational Drug Application (IND) clearances, New Drug Application (NDA)/ Abbreviated New Drug Application (ANDA) approvals, and FDA site inspections.