RAPS Institute Board of Directors

Linda is a distinguished regulatory affairs leader with more than three decades of experience shaping global regulatory strategy, intelligence, and policy. She has held senior roles at Pfizer (Seagen), Sanofi, Bayer, and GSK (Block Drug), where she built and led high‑performing teams and engaged extensively with health authorities, trade associations, industry consortia, and professional organizations worldwide. A long‑standing contributor to the advancement of the regulatory profession, Linda has been an adjunct professor in Temple University’s RAQA graduate program since 1998. She holds RAC-US, RAC-Canada, and RAC-EU and was inducted into the 2011 Class of RAPS Fellows.

Ayse Baker is the vice president of corporate regulatory affair at Corcept Therapeutics. She has over 25 years of experience in the pharmaceutical industry with a focus on building and leading regulatory affairs teams worldwide. Ayse received a PhD in chemistry from University of Illinois at Chicago, an MBA from Lake Forest Graduate School of Management, and completed her post- doctoral fellowship at Loyola University. She started her pharmaceutical career at Abbott Laboratories as a research scientist.
Ayse is a frequent speaker in national and international trade organizations and prestigious academic institutions. She was recognized for her contributions to the regulatory affairs profession and became RAPS Fellow in 2016.

David E. Chadwick recently retired as director of regulatory affairs and regulatory science for Cook Medical. In his role, he provided high-level regulatory and clinical advice on pre- and postmarket safety, quality, performance testing, compliance, and marketing issues for medical devices. David has more than 25 years of experience in the medical device industry, including many years in research and development, and clinical trials management prior to transitioning into regulatory affairs. He served as the industry representative on the FDA CDRH advisory panel on ear, nose and throat devices and as alternate on the cardiovascular panel. He is an adjunct professor for Purdue University, Bethel College in St. Paul, MN, and Ivy Tech College in Bloomington, IN. He also teaches students and regulators with the Purdue/Gates Foundation in Tanzania and serves on the advisory board for George Washington University’s regulatory affairs program.

Thomas R. Hutchinson has held senior leadership positions in regulatory affairs, quality assurance, and clinical affairs at Hygeia Sciences, Becton Dickinson, Pharmacia, Pfizer, and CR Bard. He has over 40 years of global medical products experience, including industry positions and medical research at the Oregon Health and Science University and Brown University Alpert Medical School. His experience spans the full spectrum of medical product development and commercialization, from technology assessment and product screening, successful market authorization, regulatory submissions, postapproval market support, and change management for medical devices, pharmaceuticals, biologics, combination products. He holds the Regulatory Affairs Certification (RAC), Certified Quality Manager of Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), and Certified Medical Device Auditor (CMDA) credentials, and is a RAPS Fellow.

Jennifer Neff has worked in the areas of medical devices, pharmaceuticals, and biotechnology for over 18 years. As the vice president of medical devices for Entourage, she supports leading life science companies in Europe as a consultant. Previously, she held regulatory, clinical and quality positions at Sartorius Stedim Biotech, bess AG, Bayer Health Care, Parexel Consulting, NOXXON Pharma AG, Berlin Heart GmbH, and Biotronik GmbH & Co KG. Prior to joining the industry, Jennfer worked as a veterinarian in small and large animal practices, and for the primate genetics division of the German Primate Center. She received her PhD from the University of Veterinary Medicine of Hannover and her MBA from FOM – University of Applied Science, Germany. Jennifer holds the RAC-Global and RCC-MDR credentials.

Brian Schlag is senior vice president, head of regulatory affairs and quality at Pulmovant, Inc. He has more than 25 years of experience in the pharmaceutical industry with expertise in regulatory affairs and quality assurance across multiple therapeutic areas, including pulmonary, cardiovascular, and orphan diseases. He began his career at Wyeth Pharmaceuticals as a research scientist and transitioned into quality and regulatory affairs. He subsequently held roles of increasing responsibility at Shire, Actelion and Idorsia. Brian holds a RAC-US credential and received his bachelor’s degree in chemistry from Swarthmore College, master’s in neurosciences from Washington University in St. Louis, and an master’s in regulatory affairs and quality assurance from Temple University.