Speakers

Craig Kiester, RPh, MS, RAC

Global Head, Regulatory and Quality Policy
Biocon

Craig brings with him over two decades of distinguished leadership in global regulatory affairs, most notably through his 23 years of service as an officer in the United States Public Health Service at the U.S. Food and Drug Administration (USFDA). At the USFDA, Craig held several impactful roles, culminating most recently as Division Director at the Office of Pharmaceutical Quality & Office of Programs and Regulatory Operations, CDER, where he led teams responsible for the review and management of BLAs, NDAs, and
ANDAs. His career has been marked by pioneering contributions, including playing a key role in establishing the Office of Pharmaceutical Quality in 2014, following 12 years of various roles in the Office of Generic Drugs. Earlier in his career, he also gained valuable clinical and operational experience in the hospital and home infusion pharmacy sector.

Craig holds a Bachelor of Science in Pharmacy from Duquesne University and a Master of Science in Health Science from Trident University.
On a personal note, Craig is married and his three sons are all currently in college. He enjoys traveling to island destinations, boating, sports, and spending quality time with his family. He is deeply passionate about expanding patient access to safe, high-quality, and innovative therapies worldwide.

Craig’s leadership will continue to strengthen Biocons global regulatory policies, practices, and operational excellence.