The George Washington University (GW) online Graduate Certificate in Regulatory Affairs is designed to teach working professionals the relevant, critical skills and knowledge they need to become regulatory affairs leaders in drug development.
Developed in collaboration with regulatory affairs professionals in federal agencies, including the Food and Drug Administration and the National Institutes for Health, this program integrates global regulatory strategy for drug development across the curriculum to equip you as a business leader in regulatory strategy locally and abroad.
*The total number of credits and duration of the program depend on the number of transferred credits
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The online Graduate Certificate in Regulatory Affairs program is designed to meet FDA and NIH standards. The curriculum will provide the skills to advance your knowledge in clinical research, product testing, global health, public health policy, and drug development.
Upon completion of the online certificate program, you’ll have the opportunity to transfer all 12 credits to GW’s online Master of Science in Health Sciences (MSHS) in Regulatory Affairs program.
As a graduate of the certificate program, you’ll be fully prepared to:
The online Graduate Certificate in Regulatory Affairs program is ideal for health care professionals who are either just entering the field of regulatory affairs or who wish to increase their knowledge and skills to advance to a leadership position. Students will explore the intricacies of drug development and prepare to meet FDA and NIH standards.
Students of the online Graduate Certificate program in Regulatory Affairs will learn to evaluate potential new products’ scientific and economic value in the global market, championing effective deliveries of health care products locally and abroad.
By combining interdisciplinary practices of law, science, and business in regulatory affairs, the graduate certificate program prepares students for a variety of careers in regulatory affairs. Typical roles for regulatory affairs professionals include:
Regulatory Affairs Specialist: $70,333 median salary 1
Regulatory affairs specialists develop strategies for global and local regulations for widely consumed products. They work directly with businesses and consumers to ensure the quality of products and food and drug development safety.
Regulatory Compliance Officer: $60,522 median salary 2
Regulatory compliance officers ensure companies follow regulation laws for product and drug development. These professionals are essential for quality assurance and the safety of products.
Quality Manager: $82,752 median salary 3
Quality managers work to detect problems or hazards within products developed by a company. These professionals are essential for food and drug development and protect consumers from faulty products.
To be accepted to this program, you must have:
The Graduate Certificate in Regulatory Affairs program at GW consists of 12 credit hours. Please find the cost per credit hour and total estimated program costs here.
Note: Tuition rates are subject to change and additional fees may vary by program.
GW’s experienced faculty provide you with the rich, practical knowledge and support needed for you to succeed in the program and in your career.
Dr. McGarry is the Program Director of the Leadership and Strategy in Regulatory Affairs and Clinical Research Administration. Dr. McGarry has taught Clinical Research for Regulatory Affairs in the CRL Regulatory Affairs Program for 3 years. Dr. McGarry is a board-certified internist and nephrologist with over 30 years of experience in the pharmaceutical industry, including over 15 years as a clinical and regulatory consultant. She has held positions in both large and small pharmaceutical companies including Immunomedics, Inc., Astellas Pharma, Inc., Pfizer, Inc., Zambon Corp., Ciba-Geigy Corp. (now Novartis), and ICI Pharmaceuticals (now Astra-Zeneca). These positions included senior leadership/functional and line management of global pharmacovigilance organizations, medical affairs and clinical development groups, and matrix management of multidisciplinary groups for product development teams and various special projects. Throughout her career, she has collaborated closely with regulatory affairs groups, contributing to regulatory strategic approaches, based on her experience across various pharmaceutical functions and in-depth knowledge of global health authority regulations and requirements. Her teaching experience in the pharmaceutical industry includes developing and conducting workshops and lectures for various clinical development, medical, pharmacovigilance, and regulatory topics. Dr. McGarry holds a B.S. degree in Biology from Georgetown University and an M.D. from UMDNJ-New Jersey Medical School (now Rutgers New Jersey Medical School, Newark, NJ). She completed her internal medicine residency at UMDNJ-University Hospital and Affiliated Hospitals, including Chief Resident in Internal Medicine at the East Orange, NJ Veterans Administration Medical Center and a clinical nephrology fellowship at New England Medical Center, Tufts University School of Medicine, Boston MA.
12 TOTAL CREDITS REQUIRED
The graduate certificate in Regulatory Affairs program (100% online) requires successful completion of 12 credit hours. You’ll explore topics such as the development of drugs and biologics, devices and diagnostics, clinical research in regulatory affairs, and regulatory compliance.
You can complete this graduate certificate in as little as 1 year and transfer all semester credits earned this program to the MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program.
Foundation of regulatory affairs and clinical research in therapeutic development in U.S., EU and Japan. Roles in developing products, navigating the regulatory review and approval process, and maintaining products on the market.
RAFF 6205 Regulatory Affairs Compliance (3)
Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use. Prerequisite: RCR 6201.
Overview of therapeutic development through the analyses of the critical elements of the product lifecycle, assessment of non-clinical and clinical data, and integration of strategic business needs and post-marketing efforts in planning regulatory strategy. Prerequisite: RCR 6201.
RAFF 6203 Regulatory Device Diagnostics (3)
Development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IDE, 510K, PMA. Prerequisites: RCR 6201.
The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals. Prerequisite: RCR 6201.
RCR 6206 International Regulatory Affairs and Clinical Research (3)
This course explores international regulatory requirements for the development and approval of new pharmaceutical products around the world. Prerequisite: RCR 6201.
RAFF 6207 Advertising and Promotion of Regulated Medical Products (3)
Exploration of FDA-regulated advertising and promotion of pharmaceutical drugs. Focus on pre- and post-market issues for prescription drugs and management of risks and compliance surrounding medical and commercial communications. Prerequisites: RCR 6201 and RCR 6202.
