Victor J. Gangi

Victor J. Gangi has extensive work experience in regulatory affairs and CMC (chemistry, manufacturing, and controls) in the pharmaceutical industry.

Victor J. most recently served as the Vice President of Regulatory Affairs CMC at Zenas BioPharma, where they were responsible for advising, developing, leading, and executing RA CMC strategies for the company's product pipeline. Victor J. also served as the Regulatory Co-Lead for multiple China regulatory programs.

Prior to that, Victor held the position of Senior Director of CMC Regulatory Affairs at GSK, where they provided oversight and management of a global team responsible for developing and executing regulatory CMC strategies for clinical and marketed products.

Victor J. also worked at TESARO, Inc. as Senior Director of Regulatory CMC, leading the global regulatory affairs team responsible for the biologic products portfolio. At Sanofi, they held various roles including Associate Vice President of Regulatory CMC Biologics, where they led the global regulatory CMC function for the biologic products of the Sanofi-Genzyme specialty care business.

Earlier in their career, Victor worked at Pfizer as Director of Global CMC Regulatory, overseeing regulatory activities for marketed biopharmaceutical products. Victor J. also worked at Biogen Idec as Associate Director of Regulatory Affairs CMC, coordinating regulatory activities for commercial and development biopharmaceutical products.

Before entering the industry, Victor worked at the U.S. Food and Drug Administration as an Investigator, conducting inspections and audits of pharmaceutical, biologic, and medical device manufacturers. Victor J. also worked as a Microbiologist, conducting microbiological analyses and research projects.

Overall, Victor J. Gangi has a wealth of experience in regulatory affairs and CMC, particularly in biologics and oncology therapeutics. Victor J. has demonstrated expertise in developing and executing regulatory strategies and managing global teams in the pharmaceutical industry.

Victor J. Gangi's education history begins with their Bachelor of Science (BS) degree in Microbiology from the University of Massachusetts Amherst, which they completed from 1989 to 1992. Victor J. then pursued further education and received a Master's degree in Biology (MS) from the University of Massachusetts Lowell for the years 1994 to 1996. After a gap in their education, Victor attended the University of Southern California where they earned a Master's degree in Regulatory Science from 2012 to 2016. Continuing their education, they completed their Doctor of Regulatory Science (DRSc) degree in Regulatory Science from the University of Southern California for the years 2014 to 2021. Lastly, there is no available information about their education from the Florida Institute of Technology.