Our Mission
What We Stand For
Dedicated to educational instruction and support to individuals for their professional development regarding the laws, regulations, and standards established by international, federal and state government regulatory agencies as they apply to the development, manufacture, distribution, and/or use of drugs, biologics, and medical devices.
SDRAN
Are you interested in learning more about Regulatory Affairs in the biotech and life sciences industries?
Our Board Of Directors
Kim Walker is an independent Global Regulatory, Quality, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006 with over 30 years of industry experience. She is active in non-profits, serving on the board of directors and various committees, and has managed, moderated, and presented at several professional conferences. Kim has been an SDRAN Mentoring Committee volunteer since 2009 and RAC Study Group presenter since 2014. She is a current instructor at SDSU and Roseman University and past instructor at UCI and CSUF for both graduate and undergraduate level regulatory courses.
Laura Guy, MS, RAC, earned a BS in Psychobiology from UCLA and an MS in Regulatory Affairs from SDSU. Her Company, Regulatory Liaisons, LLC provides Regulatory Affairs and Quality System services to innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, medical devices (including IVDs) and combination products. To support her clients, Ms. Guy establishes infrastructures that promote compliance with FDA/ISO/ICH/MDR regulations and standards.
Clara Feider, Ph.D., CCRA, has a passion for the clinical development of in vitro diagnostics (IVD) and devices. Clara received her B.S. in Chemistry from the University of San Francisco in 2015 and her Ph.D. in Analytical Chemistry from the University of Texas at Austin in 2020. Her academic research was focused on translating traditional analytical technics into the clinical setting to improve the diagnosis and detection of various diseases including ovarian cancer, thyroid cancer, and endometriosis.
Jingrui (Jing) brings over 6 years of invaluable experience in the pharmaceutical and medical device industries, specializing as a design control/design quality engineer. With her expertise, she has successfully led numerous projects involving drug/device combination products, in vitro diagnostic devices (IVD), companion diagnostic products, and Software as a Medical Device (SaMD) products. Serving as a design control project lead, she has effectively provided both project management and technical leadership to ensure strict compliance with U.S. FDA medical device regulations (21 CFR 820) as well as international standards such as ISO 13485, ISO 14971, IEC 62304, 62366, EU MDR and IVDR. Jing holds a Bachelor of Science degree in Biological Engineering from Cornell University and a Master of Science in Biomedical Engineering from Duke University.
Blake Schouest, PhD Blake Schouest, PhD, is a regulatory medical writer in the biotechnology industry with over 7 years of experience in research and project management. Blake works with a variety of stakeholders across multiple therapeutic areas to develop high-quality documents for regulatory submissions, including INDs, NDAs, Investigator’s Brochures, DSURs, protocols, and CSRs. He has a background in research and product development, specializing in vaccinology and immunology. Blake completed the Regulatory Affairs Essentials Program at UC San Diego Extension and conducted postdoctoral training at La Jolla Institute for Immunology.
Jennifer Wampler has 1 year of Regulatory Affairs experience in the Software as a Medical Device (SaMD) setting. Jennifer currently works at Radformation, Inc., a company that specializes in Radiation Oncology Workflow Automation, and she plays a large role in navigating global markets via International Registration. She completed an independent study program titled the Regulatory Affairs Training Program at Duke University School of Medicine through ORAQ (Office of Regulatory Affairs & Quality).
Daniel Yeh, RAC, has over ten years of experience in the Development, Manufacturing, and Commercialization of medical devices. In his current role as the Director of Regulatory and Quality at MedWaves Inc., Daniel is managing new product submissions as well as maintaining international registrations.
Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to clinical development and FDA approval. She has held various roles in preclinical research, Clinical Trial Management, Regulatory Affairs, and Project Management.
Amanda Richter, MS RAC is a regulatory drug development expert with 25 years of experience in research and development of medical products, including 18 years of experience in Regulatory Affairs. She has expertise in small molecules and biologics including gene therapies, with a focus on rare disease development. Amanda is currently Executive Director, Regulatory Strategy at Neurocrine Biosciences where she provides regulatory leadership in the development of products for the treatment of CNS disorders that include rare pediatric epilepsies.
Get In Touch
MAILING ADDRESS
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595