Vice President, APAC, PAREXEL
Dr. Chang Lee is Vice President of Consulting, APAC: Dr. Lee brings both industry and regulatory agency experience to PAREXEL. He led Regulatory and Clinical Affairs at Capsugel, KV Pharmaceuticals, Morton Grove Pharmaceuticals, TAP Pharmaceutical Products Inc., Novartis OTC, and Igenix, and served as a Medical Officer at the FDA’s Center for Drug Evaluation. U.S. board-certified in Clinical Pathology, he is knowledgeable in global clinical and regulatory product development, including risk management, and has worked with many global regulatory authorities, including FDA, EMA, the Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, the Central Drugs Standard Control Organization (CDSCO) in India, and the China Food and Drug Administration (CFDA).
Chang received his M.D. from Xian Jiaotong University Medical College (formerly Xian Medical University) in Xian, China. Dr. Lee later went to the University of Alabama at Birmingham where he received his M.S. in Health Services Administration and then his Doctor of Public Health. Dr. Lee did his residency in Pathology at the University of Chicago, is Board-Certified in Clinical Pathology American Board of Pathology, and Fellow of American College of Pathologist.