Online Graduate Certificate Programs in Regulatory Affairs


While innovations and discoveries in science and technology mark progress in our civilization, they must be guaranteed to be safe for the public to use and consume. The role of regulatory affairs, specifically in healthcare, is to ensure that all products, including medicines and drugs, biologic products, medical devices, veterinary products, nutritional products, are safe and effective. Typically, a regulatory affairs professional is involved in the entire product development lifecycle, right from research and clinical trials, to manufacturing, labelling, and surveying the post market response to the product.

Students who wish to make a career in this highly rewarding field can opt for an online graduate certificate in regulatory affairs. An online certificate allows students to study at their pace, while continuing to work. This certificate provides them with an initial purview of the field, including regulatory affairs strategy, compliance, and clinical research. A number of universities offer students the option to transfer credits earned in this certificate to a master of science (MS) in regulatory affairs, which opens doors for higher paying jobs and opportunities.

An online graduate certificate in regulatory affairs can generally be completed in one to two years, and consists of nine to 18 credit-hours. The coursework explores topics such as regulation of medical devices and diagnostics, risk management for healthcare products, FDA regulatory affairs, and international regulatory affairs.

These certificates open up several opportunities for graduates such as that of compliance specialists, regulatory affairs associates, and pharmaceutical sales representatives. They can work in industries such as food safety, pharmaceuticals, and medical device manufacturing.

Read on to find detailed overviews of seven excellent online graduate certificates in regulatory affairs and three respected faculty members in the field.

Featured Online Graduate Certificates in Regulatory Affairs

Professors to Know in Graduate Certificates in Regulatory Affairs

  • Stephen F. Amato, PhD, MBA - Northeastern University

    Dr. Stephen F. Amato heads the regulatory services department at Northeastern University. He has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. His research efforts are focussed on the regulation of biomedical product commercialization; what drives the success of commercial biomedical products; and global reimbursement for biomedical products. Notably, he has published his work in prominent journals such as the Journal of Immunology and the Journal of Experimental Medicine. He holds his PhD and MBA from Boston College.

  • C. Benson Kuo, PhD - University of Southern California

    Dr. C. Benson Kuo is an assistant professor in the Department of Regulatory and Quality Sciences. His research efforts are focussed on regulatory issues for innovative medical products and product safety in Asia.

    Along with teaching, Dr. Kuo also serves as a consultant for innovation at USC, helping students and community members with regulatory compliance, strategic planning, and submission requirements. He is also a member of professional organizations such as the Regulatory Affairs Professional Society and the Orange County Regulatory Affairs Discussion Group. He holds his PhD from UC Riverside, his MS from University of Southern California and his BS from Tunghai University.

  • Melissa Tice, PhD - George Washington University

    Dr. Melissa Tice serves as the director for the regulatory affairs program, as well as an assistant professor of clinical research and leadership at the George Washington University.

    Prior to joining GW, she served as the vice president of global regulatory affairs at Immunomedics, Inc. She brings over 30 years of work experience in the field of science and regulatory affairs to the classroom. Her expertise lies in the development of regulatory strategies for drug development, as well as obtaining the approval of global health authorities for advances in the fields of oncology, cardiovascular disease, and vaccinations. She earned her BA in chemistry from the Douglass College at Rutgers University in New Jersey and her PhD in biological chemistry from the University of Pennsylvania.

Farheen Gani
Farheen Gani

Farheen is a freelance writer, marketer, and researcher. She writes about technology, education, and marketing. Her work has appeared on websites such as Tech in Asia and Foundr, as well as top SaaS blogs such as Zapier and InVision. You can connect with her on LinkedIn and Twitter (@FarheenGani).

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