Kelsey Hoontis, MSc
Sr. Director, Regulatory Affairs (Principal Consultant-1) GRA, Boston Biodevelopment
Kelsey Hoontis MSc. is a regulatory affairs and CMC strategy leader with nearly 20 years of experience supporting global biotechnology and pharmaceutical programs, specializing in biologics and advanced modalities across major regulatory regions. She brings a practical perspective on how AI is being utilized within Regulatory Affairs and CMC, with a focus on responsible governance, ethical use, and maintaining data integrity and trust in submission-ready outputs.