Jeremy P. Hanman
Principal Consultant, GRA
Jeremy Hanman, Principal Consultant, Global Regulatory Affairs, has nearly 20 years of experience in US, EU, and global drug development throughout the entire product life cycle, including spearheading many marketing applications. He leads cross-functional teams to successfully prepare and defend successful NDA, MAAs, and J-NDA and is adept at preparing for and facilitating Health Authority meetings, including pre-NDA and Scientific Advice.
Jeremy is highly experienced in providing global regulatory oversight and strategy for all stages of clinical development, from Phase 1 first-in-human trials, global Phase 2 and Phase 3 trials to post-approval pediatric and observational registry studies. He has led cross-functional teams in preparation of regulatory submissions including PSP, PIP, briefing documents for meetings with Health Authorities, applications for Orphan Drug Designation, Breakthrough Therapy Designation, and Fast Track Designation, and INDs/CTAs and has served as the regulatory lead for multiple inspections by Health Authorities including GCP, PV, PADE and pre- and post-approval. Prior to joining Boston Biodevelopment, Jeremy successfully led a cross-functional team in preparation and defense of a NDA and MAA for Lupkynis, which was approved in 2022 for use with lupus nephritis patients.
Jeremy earned a Bachelor of Applied Science (BSc) from the University of Victoria, and an Associate Certificate Biotechnology from the British Columbia Institute of Technology.
