About

SDRAN
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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, MS, RAC, FRAPS
President

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.

Kim achieved both the US and EU RAPS RAC and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession.  Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.  She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network, helping to bridge communication and collaboration opportunities between FDA and industry and she was awarded an OCRA and SDRAN lifetime membership for her contributions to these organizations.  She has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.   Kim’s vision for her term as President of SDRAN is to work with the Board of Directors in expanding and enhancing the quality and variety of educational programs, networking, mentoring, and professional growth opportunities for SDRAN members and the general regulatory community. [email protected]
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Laura Guy, MS, RAC
President-Elect

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. 

Areas of expertise include establishing compliant Quality Systems, GXP auditing, and employee training. For regulatory submissions such as INDs, NDAs, IDEs, 510(k)s and PMAs, she assists clients with regulatory strategy to promote swift, practical and successful plans to introduce the product into the marketplace. A member of SDRAN from its conception, Ms. Guy Co-chaired VP of Programs. You may know her from teaching RAC Study Group preparation courses, classes for the SDSU MSRA program and extension courses for UCSD. As a founding member of the SDRAN Mentoring Program, she continues as a committee member. During her term as President-Elect, Ms. Guy will focus on the fundamental purpose of SDRAN—Serving our local Regulatory, Quality and Clinical professionals. When possible, SDRAN will reach out to others who share our core values and could benefit from our educational opportunities. 
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Clara Feider, Ph.D., CCRA
Co-VP of Programs

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. 

In 2021, Clara transitioned into clinical research and is currently a Sr. Clinical Research Associate at a contract research organization, CovarsaDx Corp., where she assists in the execution of clinical studies for various IVD products. Clara has been a member of SDRAN since 2020. During her time as a member, Clara has served on the Membership and Education Committees. Although she recently relocated to Pennsylvania, she looks forward to furthering her involvement in the SDRAN community and expanding upon the virtual learning opportunities that blossomed during the COVID-19 pandemic. Clara also hopes to broaden the variety of program opportunities available through SDRAN in order to increase engagement with members of the regulatory community. She aims to introduce programs that are unique, educational, and applicable to those throughout regulatory affairs and adjacent fields
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Jing (Jing) Li, MS
VP of Education

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. 

Notably, while maintaining a full-time position, she recently obtained her second Master's degree in Regulatory and Quality Science from the University of Southern California, showcasing her commitment to professional growth and continuous learning. Jing has been a dedicated volunteer for the SDRAN Education Committee for the past two years. She actively contributes to preparing and facilitating numerous Regulatory Affairs Certification (RAC) study sessions, diligently following up with instructors both before and after the meetings. In her role as the Vice President of Education for SDRAN, Jing envisions furthering her commitment to assisting members aspiring to excel in RAC Drug/Device tests. Her goal is to enhance exam preparation and support, fostering an environment that encourages 2024 Board of Directors Ballot Page 3 of 4 members to connect with like-minded individuals. She aims to facilitate the formation of discussion panels and study groups, fostering collaborative learning and knowledge exchange within the community. 
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Blake Schouest
VP of Member Relations

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. 

Blake holds a PhD in Biomedical Sciences from Tulane University School of Medicine. Serving as Secretary of SDRAN, Blake has captured minutes for Board meetings, maintained Bylaws and records, and assisted other officers as needed. Blake’s vision for his term as VP of Member Relations is to continue to grow SDRAN’s membership by organizing member events and fostering a strong networking environment. 
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Jennifer Wampler, RAC
VP of Website & Communications

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). 

She completed 10 courses and earned her Regulatory Affairs Certificate in Medical Devices via the Regulatory Affairs Professionals Society (RAPS). She attended courses hosted by Oriel STAT A MATRIX encompassing auditing a Quality Management System (QMS) using ISO Standard 13485:2016 and MDSAP (Medical Device Single Audit Program) and was certificated as a Medical Device Lead Auditor ISO 13485:2016 from Exemplar Global, Inc. She continually immerses herself in any opportunity she can find in the Regulatory Space that contributes to her growth.As a member of SDRAN for the past year, Jennifer has served as a volunteer on the SDRAN Education Committee and has moderated (& absorbed) live RAC (Regulatory Affairs Certificate) Preparatory Sessions presented by brilliant industry professionals in the Regulatory field. Jennifer’s vision for her term as Website & Communications strategist is to support SDRAN’s Board of Directors by expanding SDRAN’s outreach and information output.
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Daniel Yeh, RAC
Treasurer

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.

His regulatory work includes 510(k) submissions, managing the quality system, and responding to annual FDA and ISO audits. Outside of quality, he also oversees product development and manages clinical activities including distributor sales, product training, and other medical affairs. Daniel is a graduate of UCSD where he majored in Biology. He obtained his US RAC certification in 2012. Daniel joined the Board of Directors in 2015 and is currently serving his third term as Treasurer. He has been a volunteer with SDRAN since 2010, has served on the Education Committee as EU Group Lead and technical support since 2014, and in 2017 he was the co-chair of the committee. In addition, Daniel supports the Member Relations Committee by planning and assisting at member events. During his term as the Treasurer of SDRAN’s Board of Directors, he has successfully transitioned financial records over to a software-based system and ensured compliance with local and federal financial requirements. Daniel’s vision for his term as Treasurer is to find innovative ways to give back to membership while maintaining a fiscally responsible budget. [email protected]
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Olivia Yu, PhD
Past-President

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.

Olivia is currently a Global Program Manager at Novartis. Olivia received her Doctorate in Biomedical Sciences from the University of California, San Diego and her Bachelor’s Degree in Biochemistry/Molecular Biology from the University of California, Santa Barbara. Olivia’s vision for her term as Past-President of SDRAN is to continue to work with the Board of Directors in furthering the quality and variety of educational programs, networking, and learning opportunities for SDRAN’s members and non-members. [email protected]
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Amanda Richter, MS, RAC
VP of Mentoring

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.

Her past positions include Senior Director, Regulatory Affairs at Tocagen, where she oversaw the development of a gene therapy that was awarded breakthrough therapy and PRIME designations in the treatment of high grade glioma. Prior to Tocagen, she held positions of increasing responsibility at Ambit Biosciences, Biogen Idec, Santarus, and Integra Lifesciences. Before entering the biopharmaceutical industry, she was a post-graduate researcher at the University of California, Davis where she worked in the laboratory of Dr. Laurel Gershwin supporting vaccine research, and development of a primate model of allergic asthma. Amanda has a Bachelor of Science degree in Microbiology with an emphasis in Immunology from UC Davis and a Master of Science degree in Regulatory Affairs from San Diego State University. She is Regulatory Affairs Certified (RAC, US and EU) since 2005, and is a member of SDRAN, RAPS, and TOPRA. Since 2017, she has been a lecturer for the SDRAN RAC Study Group. Amanda’s vision for her term as VP of Mentoring is to continue to build on the previous success of the SDRAN mentoring program, further improve the experience for both mentors and mentees based on participant feedback and recommendations of SDRAN members, and expand the outreach for mentoring opportunities. [email protected]
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Jamie Brugnano, PhD, RAC
VP of Programs
Jamie Brugnano, PhD, RAC (US) has over twelve years’ experience in pharmaceuticals and biologics; six of those in regulatory affairs. She is currently Director of Regulatory Affairs at Bachem Americas where she leads a team in CMC strategy and documentation, including writing drug master files and technical packages and addressing questions from regulatory authorities globally. Jamie started her career as a research and development scientist at the intersection of bioprinting and tissue engineering and then made a successful transition into regulatory affairs. Jamie earned her doctorate in Biomedical Engineering from Purdue University and her Bachelor of Science in Biology from Harvey Mudd College.

Jamie has been a member of SDRAN since 2016 and has taken advantage of the different programs that SDRAN has to offer including RAC classes (US and EU) which helped her earn her Regulatory Affairs Certification and the mentoring program (as a mentee). Jamie has given back to SDRAN by serving as a volunteer on the Programs Committee and Education Committee and on the SDRAN Board of Directors as Secretary from 2021 through 2022. When Jamie is not working or giving back to the regulatory affairs community, she spends her time with her family. She has been happily married for 15 years to her husband, Anthony, has two wonderful kids, Landon (10) and Ava (8), and two rambunctious rescue dogs, Emmett and Chewbacca. Jamie looks forward to continuing to give back to the regulatory community by serving as the VP Programs for the next two years, if elected by the SDRAN members. Jamie’s vision for her term as VP of Programs is to continue to bring quality educational programs to members of SDRAN while being strategic in providing what is needed to SDRAN members in a post-COVID19 world. Jamie envisions bringing back some in person events to SDRAN in 2023 while continuing to capitalize on the advantages of offering virtual learning programs. Jamie is eager to hear your feedback to ensure SDRAN continues to be an organization that provides benefit to its members. [email protected]
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Articles of Corp.

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SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

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