Randal Batenhorst, BS Pharm, PharmD, is a pharmaceutical, regulatory affairs executive with more than 35 years of combined global clinical development and regulatory affairs experience from candidate selection, clinical development, registration and product maintenance, which includes extensive advertising and promotion experience.   Prior to joining the pharmaceutical industry, Randal was a tenured faculty member at the University of Illinois at Chicago College of Pharmacy and was Chief of Clinical Investigations and Vice Chair of the Institutional Review Board.   Randal served as part of the original clinical team that introduced patient-controlled analgesia to the United States.

Upon leaving academia, Randal transitioned to clinical development at Burroughs Wellcome Company and over the course of time held leadership positions within GlaxoSmithKline (GSK) and its legacy companies including a move to global regulatory affairs in 2002.  Randal led the entire clinical development program for remifentanil (ULTIVAÒ) and was responsible for its registration globally.   As a regulatory affairs professional, Randal led a countless number of pre-IND, end of phase 2, pre-NDA and post-approval meetings with FDA and similar scientific advice meetings with other international regulatory agencies, include MHRA, EMA, Health Canada, TGA (Australia) and PMDA (Japan).  Clinical development and regulatory affairs experience spanned across numerous therapeutic areas, small molecule, biologics and medical devices:   HIV, viral diseases, tropical disease, anesthesia/analgesia, rare diseases, women’s health, men’s health, neurosciences and additional medicine.

Since semi-retiring from Indivior in 2025, Randal continues to provide highly selective consultative regulatory support for projects of interest such as addiction sciences, rare diseases, and novel drug delivery systems.