The practice of regulatory affairs involves making sure that an organization’s operations adhere to the rules and laws imposed by the government. For students or regulatory affairs professionals who wish to further their careers, earning a PhD degree in regulatory affairs online is a wise choice.
Students who pursue a regulatory affairs PhD can develop the expertise needed to work for major biotech firms. Students who participate in these programs gain an understanding of the compliance procedures used in the creation of novel foods, technologies, and medications. For students wishing to work in governmental, non-governmental, and private consulting companies, several programs also have a concentration on health policy. Graduates from these programs can find employment in a variety of places, including research labs, medical device companies, and biotechnology businesses.
The following article examines six universities with outstanding regulatory affairs professors: Duke University, George Washington University, Northeastern University, Temple University, University of Southern California, and University of Washington. These faculty members are specialists in their fields, have published widely, and have a wealth of real-world regulatory and legal expertise. Their profiles are provided below.
A prestigious university, Duke University is situated in Durham, North Carolina. It is frequently rated as one of the top institutions in the nation, and Forbes classified it as one of the top ten universities that produced the most Forbes 400 billionaires last year. Duke grads are among the most sought-after and highly regarded professionals worldwide, according to The New York Times. More than a dozen Nobel laureates, three Turing Award winners, 40 Rhodes Scholars, and 25 Churchill Scholars are among the university’s former students.
The Office of Regulatory Affairs and Quality is tucked away inside the school of medicine. This division provides a regulatory affairs training program as a free resource to Duke Health’s clinical research community. The six to seven-week curriculum offers a general overview of the topic as well as a thorough examination of regulatory affairs in specific industries, such as pharmaceuticals, biologics, and medical devices. The office also hosts expert speakers from the business, academic, and governmental sides of regulatory affairs at regular events, seminars, and workshops.
BRUCE KENDALL BURNETT, PHD – Duke University
Dr. Bruce Burnett is an assistant professor of medicine at Duke University, the head of regulatory affairs, and a member of the core faculty in the innovation and entrepreneurship division. He is in charge of regulatory education, regulatory advice, and assistance with regulatory submissions in his capacity as director of the regulatory affairs department.
The results of Dr. Burnett’s research have been published in the American Journal of Respiratory and Critical Care Medicine, Biochemistry and Molecular Biology Education, and the Journal of Allergy and Clinical Immunology. Among other things, he writes about preclinical evaluation, vaccines, and clinical trials for oral immunotherapy.
The Regulatory Affairs Professionals Society has awarded Dr. Burnett the Regulatory Affairs Certification (RAC) in U.S. and European Regulations. He finished his genetics postdoctoral fellowship at Harvard Medical School and his doctorate in chemistry at the Massachusetts Institute of Technology.
George Washington University
One of the top research colleges in the nation is George Washington University, sometimes known as GW, which has its headquarters in Washington, D.C. The Milken Institute of Public Health, the School of Engineering and Applied Science, the Columbian College of Arts and Sciences, and the School of Medicine and Health Sciences all provide some of the school’s most well-known research. Politicians, CEOs, scientists, Nobel laureates, MacArthur fellows, Olympic athletes, Academy Award and Golden Globe winners, and royalty are among the graduates and professors at George Washington.
Two degrees are available for anyone interested in a career in regulatory affairs from the regulatory affairs department, which is part of the GW School of Medicine and Health Sciences. The first is an online graduate certificate in graduate studies, while the second is an online master’s degree in health science. These regulatory affairs programs teach their students how to use international regulatory tools and techniques for a variety of healthcare items, including medicines, biologics, medical devices, and diagnostics.
DANIELA DRAGO, PHD – George Washington University
The regulatory affairs program at George Washington University is directed by Dr. Daniela Drago. Clinical management and leadership, legal issues, managing clinical research, and clinical and translational research are among the subjects she teaches. She had top regulatory affairs positions at F. Hoffmann-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb before to joining the GW faculty.
Global regulatory affairs, regulatory CMC strategy, and regulatory operations management are among of her research interests. She has contributed to prestigious journals like the Journal of Molecular Catalysis, Clinical Research and Regulatory Affairs, and Journal of Organometallic Chemistry. Additionally, Dr. Drago has received the President’s Volunteer Service Award.
Dr. Drago received her undergraduate degree from l’École Polytechnique Fédérale de Lausanne, her master’s in chemistry from the Universita’ Degli Studi di Messina, and her PhD in chemistry from the Swiss Federal Institute of Technology.
Northeastern University is located in Boston, and it is most well-known for its cooperative education program (co-op), which blends academic study with professional experience. Even though it is optional, this experiential learning component is a key component of Northeastern’s programs. Notably, Northeastern has routinely placed among the top five universities for internships according to Princeton Review. The school came in first place this year.
Professionals in regulatory affairs have a variety of educational options at Northeastern, but perhaps the most notable is the master of science in regulatory affairs for pharmaceuticals, biologics, and medical devices. The curriculum equips students with the skills necessary to manage a range of regulatory operations from development through commercialization. The program is flexible and can be finished online, on one of the school’s campuses (Boston, Seattle, Charlotte, or Toronto), or in a hybrid setting. It can also be completed part-time or full-time.
The seven concentrations of operational regulatory affairs, strategic regulatory affairs systems, clinical research regulatory affairs, international regulatory affairs, regulatory compliance, general regulatory affairs, and medical device regulatory affairs allow students to focus on one of these areas in accordance with their interests.
STEPHEN F. AMATO, PHD – Northeastern University
At Northeastern University, regulatory affairs, reimbursement, pricing, and health economics are taught and advised by Dr. Stephen Amato, director of regulatory services. He is a professor at the master’s program in regulatory affairs for pharmaceuticals, biologics, and medical devices. Along with his duties as a teacher, he also manages the academic staff for the educational service programs in global regulatory affairs, quality control, and advanced manufacturing.
Global reimbursement for biomedical products, international regulation of the commercialization of biomedical products, and factors influencing the effectiveness of biomedical product commercialization are all topics covered in Dr. Amato’s study. In respectable journals including the Journal of Immunology, Cancer Research, and the Journal of Infectious Diseases, he has published his work. He is a consultant for the Regulatory Affairs Professional Society and holds Regulatory Affairs Certification (RAC) in both the United States and the European Union (RAPS).
Boston College is where Dr. Amato earned both his MBA in marketing and his doctorate in molecular and cellular biology. He graduated from Harvard College with a bachelor’s degree in biological services.
ANGELA KNOX – Northeastern University
At Northeastern University, Angela Knox teaches in the master’s degree in regulatory affairs. She supports students as they pursue careers in clinical regulatory affairs, operational and strategic regulatory affairs, and regulatory compliance. Professor Knox spent more than ten years working for clinical research groups before entering academia.
Project management, legal issues, leadership, and team-building are some of her specialties. In prestigious journals like the Journal of the American Society of Nephrology and Neurology, Professor Knox has published her findings. She also received the Partners in Excellence award from the Massachusetts General Hospital Clinical Research Team.
At Northeastern University, Professor Knox earned a master’s degree in project management with a concentration in clinical trial design; at Bates College, she earned a bachelor’s degree in neurobiology and Spanish. She also holds a Project Management Professional certification (PMP).
Although Temple University is based in Philadelphia, it also maintains eight campuses throughout Pennsylvania, Rome, and Tokyo. Temple is one of the biggest providers of professional education in the world, with schools devoted to dentistry, law, medicine, podiatry, architecture, and pharmacy. One of the nation’s leading research universities, the institution provides more than 50 doctorate and 150 master’s degree programs that advance study and research.
The first regulatory affairs program in the nation was presented by the Temple University School of Pharmacy in 1968. The master of science in regulatory affairs and quality assurance offered by the institution was created to meet the demands of professionals working in the pharmaceutical sector. Since then, the school has created additional, more specialized pre- and post-programs master’s based on student desire. These include licenses in a variety of fields, such as biopharmaceutical production, medication development, clinical trial administration, sterile process manufacturing, food regulatory affairs, and quality control. Notably, every program is accessible online.
BARRY BERGER, JD – Temple University
Barry Berger teaches regulatory affairs at the pharmacy school at Temple University. He instructs students in drug development, advanced issues in food and drug law, and food and drug law. He worked in various-sized pharmaceutical and biotech companies for 30 years prior to entering academia. He has held prominent roles at GlaxoSmithKline, Aventis(RPR), Praxis Biologics, Bausch & Lomb, and Schering-Plough in the areas of regulatory law, employment law, and corporate compliance.
The regulatory, legal, and business concerns that have an international influence on biologics, medical devices, and pharmaceuticals are the main topics of Professor Berger’s study. Additionally, Professor Berger belongs to numerous professional associations, including the American Bar Association and the Drug Information Association. He received his bachelor’s degree from City College of New York, a Juris Doctor (JD) from Temple University, and his MBA in management from Rutgers University.
University of Southern California
The oldest private research university in California is University of Southern California. The institution, which is based in Los Angeles, contributes $8 billion in annual economic activity to the county and state’s economies. Additionally, during the 2016–17 academic year, the institution earned more than $764 million in funded research. In the fields of commerce, politics, athletics, and medicine, USC has produced numerous noteworthy graduates and faculty members, including several Nobel laureates.
SUSAN BAIN DRSC – University of Southern California
Dr. Susan Bain is an assistant professor of regulatory and quality sciences. She has prior experience working in a variety of sectors, including biotechnology, pharmaceuticals, and medical equipment. She formerly held different top executive positions with organizations like Peregrine Corporation, Watson Pharmaceuticals, and Baxter Healthcare, where she served as vice president of quality and regulatory assurance and operations.
She received a BS in biological science from Cal Poly, Pomona, as well as a DRSc and MS in regulatory science from USC.
EUNJOO PACIFICI, PHD, PHARMD – University of Southern California
At the USC School of Pharmacy, Dr. Eunjoo Pacifici oversees the International Center for Regulatory Science and teaches courses on regulatory and quality sciences. She offers classes on writing regulatory submissions, the globalization of the biomedical industry, medical product regulation, and international approaches to medical product regulation.
Her research focuses on areas such as clinical research and drug laws, global approaches to product development, R&D in emerging markets, and creative methods for designing and carrying out clinical trials. Numerous prestigious journals, like the Journal of Neurochemistry and the Journal of Free Radical Biology and Medicine, have published a lot of Dr. Pacifici’s work.
She earned a bachelor’s degree in biochemistry from the University of California, Los Angeles, and two doctorates—one in toxicology and the other in pharmacy—from the University of Southern California.
University of Washington
Just ten years after Seattle’s founding, the University of Washington, also known as U-Dub, was established to support the growth of the city’s economy. The public research organization, which has its headquarters in downtown Seattle, is well-known for its work in science and medicine research and for possessing one of the largest library systems in the world. Twenty Nobel laureates, numerous Pulitzer Prize winners, Fulbright Scholars, and other eminent professionals are among the alumni of this prestigious institution.
The UW School of Pharmacy houses the school’s regulatory affairs programs. The School of Pharmacy was named as the ninth-best pharmacy school in the nation by U.S. News & World Report. According to their interests, students who are interested in regulatory affairs can enroll in a master’s program in biomedical regulatory affairs or different certificate programs.
JEAN FEAGIN, PHD – University of Washington
Dr. Jean Feagin is a senior instructor in biomedical regulatory affairs for the UW School of Pharmacy’s master of science program. She collaborates with other master’s program leaders in regulatory studies to discover shared interests and assists students with their regulatory projects at for-profit and nonprofit businesses.
Her research interests focus on public health, regulatory issues, and the supply of appropriate, safe, and effective medical technology. Her areas of interest include infectious diseases, pharmaceuticals and medical product regulation, and biotechnology. Her writings have been published in Molecular and Biochemical Parasitology, Eukaryotic Cell, and PLoS ONE. She received the Department of Pathobiology’s 2006 Teaching Award.
Dr. Feagin earned her bachelor of arts in biology from Macalester College and her doctorate in biological sciences from Stanford University.
TOM HAZLET, DRPH, PHARMD – University of Washington
The University of Washington School of Pharmacy’s master’s program in biomedical regulatory affairs is under the direction of Dr. Tom Hazlet. In the biomedical regulatory affairs certificate program, he teaches classes on the overview of biomedical regulatory affairs, methodologies in pharmaceutical policy analysis, and pharmacy law and ethics.
Dr. Hazlet’s previous positions included regulatory affairs at the California Department of Health Services, pharmaceuticals at a community hospital, and industrial microbiology for the Baxter Healthcare Corporation. He is a member of the Pacific Region Biotechnology team of the U.S. Food and Drug Administration and focuses his research on bioethics, drug regulation, and pharmaceutical policy.
Dr. Hazlet received his PhD in pharmacy from the University of California, San Francisco and his doctorate in public health from the University of California, Berkeley. He also holds a biology bachelor’s degree from the University of Redlands.
See also: Masters in Business Analytics Canada