collagePHARMACEUTICAL SCIENCES/REGULATORY AFFAIRS AND QUALITY ASSURANCE, PH.D.
ABOUT THE PROGRAM
The School of Pharmacy offers a graduate program leading to the Ph.D. in Pharmaceutical Sciences with a concentration in Regulatory Affairs and Quality Assurance (RAQA). Emphasis is placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety profiling, and post-approval processes. The program applies academic research methods to current industry regulatory issues, enabling candidates to pursue a dissertation that helps to define and resolve regulatory or quality problems with data research and scientific methodology. The goal of each dissertation is to present new and thoughtful answers to industry questions and problems that result in cost savings, safer and/or more effective products, better safety profiles, and other benefits for patients and manufacturers.
The RAQA concentration is designed for professionals who have a minimum of 15 years of relevant work experience, including supervisory responsibilities, in pharmaceutical and related sciences and/or regulation in such areas as analytical methods, clinical and pharmacovigilance supervision, corporate drug development or manufacturing science, quality practices, validation implementation, and other pertinent industry practices that draw heavily on regulatory policy and quality assurance. Work experience must be applicable to the topic candidates plan to investigate for their dissertation.
Selection is highly competitive as a very limited number of candidates is accepted each year. Successful candidates are expected to have:
- a master’s degree or the equivalent in a pharmaceutical, science, medical, engineering, or related field;
- a minimum of 15 years of work experience in the field related to their Ph.D. dissertation;
- current work experience that can be applied to the regulatory/quality topic to be investigated for their Ph.D. dissertation;
- the ability to work both independently and as part of a team, displaying recognizable initiative;
- a willingness to pursue original, independent research, utilizing a multidisciplinary approach to problem solving;
- strong communication skills, both verbal and written, including the ability to write academic research papers containing original thought and cogent arguments;
- basic knowledge of data analysis, having completed at least one course in statistical methods; and
- the ability to accept constructive criticism and welcome feedback provided by the Dissertation Advisor and Dissertation Advisory Committee.
Time Limit for Degree Completion: 7 years
Campus Location: Health Sciences Center, Fort Washington
Courses may also be offered at Main campus. Research must be carried out, however, at the Health Sciences Center campus under the supervision of an advisor who is a member of the Graduate Faculty.
Full-Time/Part-Time Status: The degree is completed on a part-time basis in 2 to 5 years. Successful candidates are expected to pursue the Ph.D. program at least two terms every academic year (Fall, Spring, or Summer) until the dissertation is completed. Typically, students pursue the Ph.D. every Fall and Spring term, but a Summer term may be substituted. Note that a minimum of one credit each Fall and Spring term is required to maintain the candidate’s active student status.
Job Prospects: Job opportunities include positions as postdoctoral researchers, scientists in the pharmaceutical industry, and faculty members.
Non-Matriculated Student Policy: Non-matriculated students are ineligible for participation in the program.
Universities with an Outstanding Faculty in Regulatory Affairs
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Regulatory affairs programs deal with the regulatory and legal aspects of healthcare. This is a dynamic field as the rules and regulations surrounding healthcare are always evolving. Students with a degree in regulatory affairs can pursue careers in biomedical engineering, biotechnology, and bioscience. All businesses in these fields, big or small, need to comply with rules. Hence the need for regulatory affairs expertise and trained professionals in the field is high.
A master’s degree in regulatory science helps students gain the skills and knowledge to work with large biotech companies. These programs help students understand compliance processes in the development of new medicines, devices, and food products. Some programs also have a specific focus on health policy, which can be useful for students looking to work in governmental, non-governmental, and private consulting organizations. Graduates from these programs can work in diverse settings such as a research lab, with a medical device agency, or in biotechnology firms.
The following article explores six schools—Duke University, George Washington University, Northeastern University, Temple University, the University of Southern California, and the University of Washington—with exceptional regulatory affairs professors. These faculty members, profiled below, are experts in their field, have been widely published, and have extensive real-world regulatory and legal experience.
Duke University
Duke University, located in Durham, North Carolina, is a world-renowned school. It is consistently ranked among the best schools in the country, and last year, Forbes listed the school among the top ten universities to produce the most Forbes 400 billionaires. The New York Times has also noted that Duke graduates are some of the most sought-after and valued professionals in the world. The university counts more than one dozen Nobel laureates, three Turing Award winners, 40 Rhodes Scholars, and 25 Churchill Scholars among its alumni.
Nestled within the school of medicine is the Office of Regulatory Affairs and Quality. This department is a no-cost resource to the clinical research community at Duke Health that offers a training program in regulatory affairs. The six- to seven-week program provides an overview of the profession and an in-depth look at regulatory affairs within certain fields, such as drugs, biologics, and medical devices. The office also holds regular events, seminars, and workshops, and hosts expert speakers from the professional, academic, and governmental corners of regulatory affairs.
BRUCE KENDALL BURNETT, PHD – Duke UniversityDr. Bruce Burnett is the director of regulatory affairs at Duke University, an assistant professor in medicine, and a core faculty member in the innovation and entrepreneurship department. As the director of regulatory affairs department, he oversees regulatory education, regulatory consultation, and support for regulatory submissions.Dr. Burnett’s research has appeared in the Journal of Allergy and Clinical Immunology, Biochemistry and Molecular Biology Education, and the American Journal of Respiratory and Critical Care Medicine. He writes about oral immunotherapy clinical trials, vaccines, and preclinical evaluation, among other topics.Dr. Burnett holds the Regulatory Affairs Certification (RAC) in U.S. and European Regulations from the Regulatory Affairs Professionals Society. He completed his doctorate in chemistry at the Massachusetts Institute of Technology and an NIH postdoctoral fellowship in genetics at Harvard Medical School.
George Washington University
George Washington University—often referred to as GW—is based in Washington, D.C. and is considered one of the best research universities in the country. Some of the school’s most prominent research comes out of 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. George Washington alumni and faculty include politicians, chief executives, scientists, Nobel laureates, MacArthur fellows, Olympic athletes, Academy Award and Golden Globe winners, and royalty.
The regulatory affairs department is located within the GW School of Medicine and Health Sciences and offers two degrees for aspiring regulatory affairs professionals. The first is an online master’s degree in health science and the second is an online graduate certificate. Students within these regulatory affairs programs learn how to apply global regulatory tools and strategies for all kinds of healthcare products, including drugs, biologics, medical devices, and diagnostics.
DANIELA DRAGO, PHD – George Washington UniversityDr. Daniela Drago is the director of the regulatory affairs program at George Washington University. She teaches clinical management and leadership, regulatory affairs, clinical research administration, and clinical and translational research. Before joining the GW faculty, she held senior regulatory affairs roles at F. Hoffmann-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb.Her research foci include global regulatory affairs, regulatory CMC strategy, and regulatory operations management. She has published her work in prominent journals such as the Journal of Organometallic Chemistry, Clinical Research and Regulatory Affairs, and the Journal of Molecular Catalysis. Dr. Drago is also a winner of the President’s Volunteer Service Award.Dr. Drago earned her doctorate in chemistry from Swiss Federal Institute of Technology, her master’s in chemistry from the Universita’ Degli Studi Di Messina, and her undergraduate degree from l’École Polytechnique Fédérale de Lausanne.
Northeastern University
Northeastern University is a Boston-based private institution perhaps best known for its cooperative (co-op) education program, which combines classroom work and professional experience. While not required, this experiential learning element is a fundamental pillar to Northeastern’s offerings. Notably, Princeton Review has consistently ranked Northeastern in the top five best schools for internships. This year, the school ranked first.
Northeastern offers many academic options for regulatory affairs professionals: most notably, a master of science in regulatory affairs for drugs, biologics, and medical devices. The program prepares students to manage a variety of regulatory activities throughout the regulatory process, from discovery to commercialization. The program is flexible and can be completed part-time or full-time and online, at one of the school’s campuses (Boston, Seattle, Charlotte, or Toronto), or in a hybrid format.
Students can also specialize in one of seven concentrations according to their interests: operational regulatory affairs, strategic regulatory affairs systems, clinical research regulatory affairs, international regulatory affairs, regulatory compliance, general regulatory affairs, and medical device regulatory affairs.
STEPHEN F. AMATO, PHD – Northeastern UniversityDr. Stephen Amato is the head of regulatory services and a professor and advisor in regulatory affairs, reimbursement, pricing, and health economics at Northeastern University. He teaches courses in the master of science in regulatory affairs for drugs, biologics, and medical devices program. Along with his teaching responsibilities, he also oversees the faculty for the global regulatory affairs, quality assurance, and advanced manufacturing educational service programs.Dr. Amato’s research explores global reimbursement for biomedical products, global regulation of biomedical product commercialization, and what drives the success for biomedical product commercialization. He has published his work in reputable journals such as the Journal of Immunology, Cancer Research, and the Journal of Infectious Diseases. He has received Regulatory Affairs Certification (RAC) in the U.S. and the European Union and he is also a consultant for the Regulatory Affairs Professional Society (RAPS).Dr. Amato completed his doctorate in molecular and cellular biology and master’s in business administration (MBA) in marketing at Boston College. He has a bachelor’s degree in biochemical services from Harvard College.
ANGELA KNOX – Northeastern UniversityAngela Knox is part of the faculty for the regulatory affairs master’s program at Northeastern University. She guides students to meet their career goals in operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance. Before going into academia, Professor Knox worked at clinical research organizations for more than a decade.Her areas of expertise include project management, regulatory affairs, leadership, and team-building. Professor Knox has published her research in top-notch journals such as the Journal of the American Society of Nephrology and Neurology. She is also a recipient of the Partners in Excellence award from the Clinical Research Team at Massachusetts General Hospital. Professor Knox completed her master of science in project management degree with a specialization in clinical trial design at Northeastern University and her bachelor’s degree in neuroscience and Spanish at Bates College. She is also a certified Project Management Professional (PMP).
Temple University
Temple University is located in Philadelphia but has eight additional campuses in Pennsylvania, Rome, and Tokyo. With professional schools dedicated to dentistry, law, medicine, podiatry, architecture, and pharmacy, Temple is one of the largest providers of professional education in the world. The school offers more than 50 doctoral and 150 master’s degree programs that contribute to research and scholarship making it one of the top-tier research universities in the country.
The Temple University School of Pharmacy offered the country’s first regulatory affairs program in 1968. The school’s master of science in regulatory affairs and quality assurance was designed to serve the needs of professionals within the pharmaceutical industry. Since then, the school has designed additional pre- and post-master’s programs that are more specialized according to student interest. These include certificates in biopharmaceutical manufacturing, drug development, clinical trial management, sterile process manufacturing, food regulatory affairs and quality assurance, and many more. Notably, all programs are available online.
BARRY BERGER, JD – Temple UniversityBarry Berger is a regulatory affairs professor at the Temple University School of Pharmacy. He teaches courses on food and drug law, advanced topics in food and drug law, and drug development. Before going into academia, he spent 30 years working at pharmaceutical and biotech companies of all sizes. He held senior positions related to regulatory law, employment law, and corporate compliance at GlaxoSmithKline, Aventis(RPR), Praxis Biologics, Bausch & Lomb, and Schering-Plough.Professor Berger’s research efforts are focused on regulatory, legal and business issues that impact biologics, medical devices, and pharmaceuticals on a global scale. Professor Berger is also a member of several professional organizations such as the American Bar Association and Drug Information Association. He earned his Juris Doctor (JD) from Temple University, MBA in management from Rutgers University, and his bachelor’s degree from the City College of New York.
University of Southern California
The University of Southern California is the oldest private research university in California. Located in Los Angeles, the school is a large driver of the county and state’s economy contributing $8 billion annually on economic activity in the region. What’s more, the school received more than $764 million in sponsored research in the 2016-17 fiscal year. USC counts many notable alumni and faculty in business, politics, athletics, and medicine, including several Nobel laureates.
The Department of Regulatory and Quality Sciences is located within the USC School of Pharmacy. While the department was only formed in 2017, it was built upon the School of Pharmacy’s long-standing reputation for excellent regulatory science education, which began in 1999. The department provides master’s programs in regulatory science, the management of drug development, medical product quality, and regulatory management, as well as six graduate certificates in various regulatory affairs fields. In 2008, the school began offering the country’s first professional doctorate in regulatory science.
MICHAEL JAMIESON, DRSC – University Of Southern CaliforniaDr. Michael Jamieson has been a professor in the regulatory science program at USC since it was launched. Today, he also serves as the associate director of the school’s International Center for Regulatory Sciences.His research examines the development of new models to conduct joint research projects, the regulatory support of university-based researchers, data integrity in academic research, and the development of sound research practice guidelines. He is currently working on papers such as “Data Reproducibility Initiative for Translational Research“ and “Allopregnanolone: a Regenerative Therapy for Alzheimer’s.” His work has been published in Therapeutic Innovation & Regulatory Science, among others.Dr. Jamieson completed both his master’s in regulatory science and doctorate in regulatory science at the University of Southern California.
EUNJOO PACIFICI, PHD, PHARMD – University Of Southern CaliforniaDr. Eunjoo Pacifici teaches classes on regulatory and quality sciences at the USC School of Pharmacy and heads the International Center for Regulatory Science. She teaches courses on medical product regulation, international approaches to medical product regulation, the globalization of the biomedical industry, and writing regulatory submissions.Her research efforts are focused on topics that include clinical research and drug regulations, international approaches to product development, research and development in emerging markets, and novel approaches to clinical trial design and implementation. Dr. Pacifici’s work has been widely published in top journals such as the Journal of Neurochemistry and the Journal of Free Radical Biology and Medicine.She completed two doctoral degrees at the University of Southern California—one in toxicology, the other in pharmacy—and holds a bachelor’s degree in biochemistry from the University of California, Los Angeles.
University of Washington
The University of Washington, affectionately known as U-Dub, was founded just a decade after Seattle was founded to help with the city’s economic development. The school, located in downtown Seattle, is a public research institution known for its research in medicine and science and for having one of the largest library systems in the world. The school’s alumni community includes 20 Nobel Prize laureates, many Pulitzer Prize winners, Fulbright Scholars, and other distinguished professionals.
The school’s regulatory affairs programs can be found within the UW School of Pharmacy. The U.S. News & World Report ranked the School of Pharmacy as the ninth best pharmacy school in the country. Students interested in regulatory affairs can enroll in a master of science in biomedical regulatory affairs or various certificate programs according to their interest.
JEAN FEAGIN, PHD – University Of WashingtonDr. Jean Feagin is a senior lecturer of biomedical regulatory affairs in the master of science program at the UW School of Pharmacy. She helps students undertake regulatory projects at commercial and non-profit organizations and works in coordination with other master’s degree program leaders in regulatory studies to identify common interests.Her research foci include public health and regulatory affairs, as well as the provision of safe, effective, and appropriate medical technology. Her expertise lies in biotechnology, drug and medical products regulation, and infectious diseases. Her articles have appeared in PLoS ONE, Molecular and Biochemical Parasitology, and Eukaryotic Cell. She won the 2006 Teaching Award from the Department of Pathobiology.Dr. Feagin completed her doctoral degree in biological sciences at Stanford University and her bachelor of arts in biology at Macalester College.
TOM HAZLET, DRPH, PHARMD – University Of WashingtonDr. Tom Hazlet directs the master of science in biomedical regulatory affairs program at the University of Washington’s School of Pharmacy. He teaches courses on the survey of biomedical regulatory affairs, methods in pharmaceutical policy analysis, and pharmacy law and ethics within the biomedical regulatory affairs certificate program.Before teaching, Dr. Hazlet worked in industrial microbiology for the Baxter Healthcare Corporation, in pharmaceuticals at a community hospital, and in regulatory affairs at the California Department of Health Services. His research efforts focus on bioethics, drug regulation, and pharmaceutical policy and he is part of the U.S. Food and Drug Administration’s Pacific Region Biotechnology team.Dr. Hazlet earned his doctorate in public health in health policy and administration from the University of California, Berkeley and his doctor of pharmacy from the University of California, San Francisco. He also has a bachelor of science in biology from the University of Redlands.
Methodology
MHAOnline used the following criteria to select professors for inclusion in this list:
- University affiliation: Professors must be actively teaching at an accredited university in the U.S.
- Publication: They have published their research in influential peer-reviewed journals and presented it at industry conferences.
- Institutional and peer recognition: They have received awards, distinguished titles, notable grants, and research funding.
- Professional commitment: They have built curricula and programs, become leaders in professional organizations, volunteered extensively in their communities, and/or consulted for companies in the field.
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