Global Clinical Development and Regulatory Affairs at Luye Pharma Group Ltd
Jean has over 12 years of experience in the Clinical Operations and Regulatory Affairs area of Clinical Research. She is a knowledgeable clinical research professional and her career path has given her well-rounded experience in Drug, Device and Biologic research, in addition to overseeing and performing clinical operations. Her credentials include a BS in Business, MS in Clinical Research Administration, proficiencies in generally accepted research practices (GCP, ICH and FDA Code of Federal Regulations) as well as management and leadership skill sets. During her career, Jean has worked on trials in the United States (US), Japan, China, Europe and South America. Her extensive experience includes the Clinical Research Organization (CRO) and Pharmaceutical side of research as well as the Regulatory Affairs side including Investigational New Drug (IND) Submissions and meetings with Federal Drug Administration (FDA).