Scott D. Tomsky, Vice President and Global Head of Regulatory Affairs at Biocon, has nearly 30 years of experience in the pharmaceutical industry. Throughout his career, he has held roles in R&D, Quality Control, and Regulatory Affairs, with prior experience at Johnson & Johnson, Ranbaxy, Teva, and Merck/Organon. His regulatory expertise spans APIs, sterile products, solid and liquid dosage forms, transdermal and inhalation products, drug-device combination products, and biosimilars. Scott is actively involved in AAM and the Biosimilars Forum and recently served on the industry negotiating team for BsUFA IV. He also previously served on AAM’s GDUFA II negotiating and implementation teams and was a member of the industry GDUFA III negotiating team. He holds a B.S. in Biology with a minor in Chemistry from Trenton State College in New Jersey and an M.S. in Quality Assurance and Regulatory Affairs from Temple University in Pennsylvania.