Advancing the Profession
One of the first programs in this dynamic arena, the Department of Regulatory and Quality Sciences remains a global leader in producing professionals with the knowledge and skills to manage regulated biomedical products worldwide. This rapidly growing and increasingly global field encompasses every aspect of pharmaceutical and medical device development, quality assurance and clinical trials oversight—helping shepherd life-improving and often lifesaving advances to the marketplace.
The Department of Regulatory and Quality Science is hosting an MSRM Information Session for postdoctoral scientists and clinicians interested in the life sciences industry. Lunch will be provided.
James Wabby, MHMS, Doctor of Regulatory Science candidate and Adjunct Assistant Professor at the Department of Regulatory and Quality Sciences co-published an article on challenges and opportunities posed by emerging digital health technologies. 
A unique aspect of the Doctor of Regulatory and Sciences (DRSc) program at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences is the opportunity to travel throughout Europe or Asia to meet international regulators and learn about global regulatory strategy. Over the course of two weeks, the incoming Fall 2022 cohort visited Vietnam, Singapore, and Thailand, gaining valuable experience in presenting to a global audience and submerging themselves into the global aspects of regulatory science, all while developing a lasting bond that will endure throughout their journey as the next DRSc cohort.
Please join Dr. Richmond in congratulating Laura Kupsch on the successful defense of her dissertation, “Contract Research Organizations – A Survey of Industry Views and Outsourcing Practices." Congratulations, Dr. Kupsch!
USC School of Pharmacy, Department of Regulatory and Quality Sciences adjunct professor, Roger Clemens, DrPH, has added five more publications to his running list of more than 80 manuscripts on nutrition, food science, and toxicology. 
A true embodiment of collaboration by Doctor of Science in Regulatory Science candidates, “A Novel Maturity Index for Assessing Medical Device Startups" has been accepted for publication in the Journal for Clinical Translational Sciences. The authors developed a novel MedTech Startup Maturity Index (SMI) as an assessment and educational tool for startup medical device companies, pediatric medical device accelerators, and MedTech investors.
Please join Dr. Richmond in congratulating Martin Koning-Bastiaan on the successful defense of his dissertation, “Institutional Review Board Implementation of the Single IRB Model for Multicenter Clinical Trials." Congratulations, Dr. Koning-Bastiaan!
Please join Dr. Richmond in congratulating Hai Luong on the successful defense of his dissertation, “Regulatory CMC Strategies for Gene and Cell Therapies During Mergers and Acquisitions: A Survey of Industry Views." 
USC Faculty from the Department of Regulatory and Quality Sciences were interviewed by Phoenix TV, a Chinese television station, about the interdisciplinary education agreement between the USC and National Cheng Kung University (NCKU)in Taiwan. Dr. Frances Richmond, Dr. Pacifici and Dr. Benson Kuo talked about the importance of interdisciplinary efforts between biomedical sciences and regulatory science to improve global health.
Students, faculty, and staff from the USC Department of Regulatory and Quality Sciences participated in the Drug Information Association (DIA) Global Annual Meeting in Chicago, Illinois—the first DIA in-person global convergence since the start of the pandemic.
The University of Southern California (USC) and National Cheng Kung University (NCKU) announced on May 24 a partnership that creates new educational opportunities for NCKU students in the growing, high-demand fields of regulatory science and biomedical engineering.Programs
Center for Regulatory Science
Aligning Regulatory Standards for Global Impact
What is Regulatory Science?
Resources to learn all about our field
- From Microscope to Market
- School Hosts International Medical Regulators Forum
- A Progressive Degree Yields Results for a Progressive Student
- Quality Counts in New Master’s Degree at School of Pharmacy
- Director of Regulatory Science program receives Award for Excellence
- USC Pharmacy Program Targets Drug Development
- Options in Regulatory Affairs – Specialties and Skill Sets
- Regulatory Science: Researchers in the Pipeline – Nature
- All in the Details: Careers in Regulatory Science – Science
- 5 High-Paying Science Jobs and How to Get Them – Money
- Perspectives on an Alternative Career Path in Regulatory Science
- Medical Device Skill Training for Entry-Level Workers: Help Is On The Way
- FDA: Why You Should Care About Regulatory Science
Industry Relevant
Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communication, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of regulatory and quality sciences—from shaping individual company strategies to ushering in systemic change to advance the entire profession. We also focus on regional and cultural sensitivities, comparative regulations and other knowledge critical for the rapid globalization of regulatory science.
There is a growing need for talent with skillsets that combine scientific foundation, business understanding and regulatory knowledge. A graduate degree in regulatory science can prepare students for a career in this industry that is both exciting and rewarding.
Eunjoo Pacifici, PharmD, PhD
Highlights / Benefits
Flexible and Individualized
In keeping with the versatility of regulatory and quality sciences as a career path, our programs emphasize flexibility and customization. They are tailored to accommodate busy professionals and designed to meet your current needs and long-term goals. You set your own pace, taking the number of classes you prefer, when and where you need them—on weekends and evenings, online, in the classroom or in a blended format. Class sizes are kept intentionally small to foster networking and group interactions. Individual classes can also be taken without enrolling in a graduate program. If you later choose to apply and are accepted, the coursework you have completed prior to admission will count toward your graduate certificate or master’s degree. And as you continue to progress in your career, you can come back and earn your doctorate. We focus on the whole person, individualizing your experience in the program and helping you forge a career path that’s suited to you alone. You’ll have the chance to take advantage of unique training opportunities through industry, government and other internships.
Rigorous and Interdisciplinary
Our world-renowned faculty combine industry experience with academic excellence. All have earned advanced degrees in regulatory science and related disciplines. Students also benefit from the insight and knowledge of outstanding speakers who have worked at the highest levels in the public and private sectors. Whether core faculty, adjunct professors or guest lecturers, these experienced leaders become part of your professional network. Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communication, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of the field—from shaping individual company strategies to ushering in systemic change to advance the entire profession. We also focus on regional and cultural sensitivities, comparative regulations and other knowledge critical for the rapid globalization of regulatory science.
Our students gain hands-on experience in project design, execution and management. Through the Theme-based Regulatory and Quality Solutions (TRAQS) program, interdisciplinary teams of students collaborate to solve a real-world challenge posed by a leading company.
Lifelong, Global Network
The Trojan Family is legendary, with good reason. Our motto, “lifelong, worldwide” reflects the longstanding commitment of USC graduates to supporting new generations of Trojans as well as the network’s extension to every corner of the globe. Alumni serve as mentors, career coaches and guest lecturers. They identify employment opportunities for students and fellow graduates and participate in our frequent career fairs—often hiring students as interns and graduates for permanent positions.
Our intimate class sizes foster bonds among fellow students and faculty. Many of your classmates have extensive experience in the industry, so you also have the chance to learn from their unique backgrounds and insights. Faculty are eager to mentor and support students on their path to success.
USC’s strong worldwide presence is also an asset to our students and alumni as the demand for regulatory professionals with an international perspective continues to grow.
Meet the Faculty
Frances J. Richmond, PhD
- Director of the D. K. Kim International Center for Regulatory Science & Professor of Regulatory and Quality Sciences
Nancy Pire-Smerkanich, DRSc, MS
- Assistant Professor of Regulatory and Quality Sciences
Eunjoo Pacifici, PharmD, PhD
- Chair & Associate Professor of the Department of Regulatory and Quality Sciences
C. Benson Kuo, PhD
- Assistant Professor
Terry David Church, DRSc, MA, MS
- Assistant Professor of Regulatory and Quality Sciences
Susan Bain, DRSc
- Assistant Professor of Regulatory and Quality Sciences
Opening Doors of Opportunity
Browse our department viewbook to learn more about our pioneering and comprehensive curriculum, the USC Department of Regulatory and Quality Sciences at USC Mann is internationally renowned for preparing new leaders in this dynamic industry.