Trained at the doctoral level and holding Regulatory Affairs Certification, he has more than 15 years of experience working in pharmaceutical regulatory affairs with an emphasis on FDA-regulated products. His work involves developing regulatory strategies and supporting approval processes for drugs, biologics, medical devices, and dietary supplements, including coordination with the FDA and Institutional Review Boards on submission and compliance requirements.

His experience includes preparing and filing IND and IDE applications, drafting regulatory correspondence and annual reports, and responding to FDA audits. He has also participated in clinical trial oversight activities such as monitoring studies, conducting GCP audits, and assisting with regulatory compliance training, while contributing to FDA meeting preparation and submission strategy development for clinical investigators and product sponsors.

In addition to regulatory work, he is a registered patent agent with experience in biotechnology-related intellectual property, including drafting patent applications, conducting prior art analysis, and supporting prosecution activities. He has also held academic and consulting roles involving instruction in FDA regulations and clinical trial frameworks, and has provided expert witness services in matters involving regulatory compliance, approval pathways, and pharmaceutical industry practices.

His educational background includes a Ph.D. in Biomedical Sciences, postdoctoral research training in medicine, a Master of Science in Regulatory Science, and a Bachelor of Science in Biology. He also holds Regulatory Affairs Certification (RAC), supporting his expertise in pharmaceutical regulation, clinical research compliance, and FDA-regulated product development.