USC Regulatory and Quality Sciences
On cover:
Mana Rahimian (Left), Nabeela Jahangeer (Right)
(Photo by Isaac Mora/USC Mann)
Welcome to USC
Vassilios Papadopoulos Dean
John Stauffer Decanal Chair in Pharmaceutical Sciences
“At USC Mann, we attract students who share our commitment to innovation and our desire to solve intractable health issues, shape the future of the profession and improve the lives of people everywhere.”
Eunjoo Pacifici Chair, Department of Regulatory and Quality Sciences
“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 an exciting and rewarding career in this industry.”
What is Regulatory Science?
Regulatory science relates the regulatory and legal requirements of biomedical product development to the scientific research needed to ensure the safety and efficacy of those products. It is an emerging profession experiencing tremendous growth. The rapid expansion of the biomedical industry has resulted in a particularly large and unmet demand for regulatory professionals.
Our programs are designed to produce graduates whose backgrounds in biological, pharmaceutical, and biomedical sciences are enhanced by the knowledge and skills needed to manage regulated biomedical products.
FDA - Regulated Sectors
• Food
• Drugs
• Medical devices
• In-vitro diagnostics
• Biologics
• Vaccines
• Cellular and gene therapies
• Stem cell therapies
• Blood and tissue products
• Radiation-emitting electronics
• Cosmetics
• Dietary supplements
• Veterinary products
• Tobacco products
Shape Your Future in Regulatory and Quality Sciences at USC
At USC, we prepare you for a successful career in the dynamic field of Regulatory and Quality Sciences. Our graduate certificates, master’s, and doctoral degree programs are designed to meet your unique career aspirations.
What sets USC apart is our strong integration of academic learning with hands-on industry experience. Through innovative initiatives like the Team-based Regulatory and Quality Solutions (TRAQS) program and the Translational Regulatory Consulting Center, students gain real-world insights while collaborating with industry experts on impactful projects. Our DK Kim International Center for Regulatory Science provides the perfect setting for students to pursue regulatory policy research.
These unique opportunities not only provide essential skills and knowledge but also equip you with the leadership and problem-solving abilities needed to excel in an ever-evolving regulatory and quality landscape. At USC, your education isn’t just about earning a degree—it’s about shaping your future as a leader in the field.
Why USC?
Nations 1st and only Doctorate in Regulatory Science 1st
4
STEM designated masters programs
6
graduate certificates
student - faculty ratio 20:1
8
USC International offices
average number of years of faculty industry experience 20+
850+
$148,888 alumni
average salary for a Regulatory Affairs Manager salary.com (Jan 2025)
Personalize your path
USC offers a full spectrum of educational opportunities in regulatory and quality sciences, including graduate certificates, master’s programs, and the only doctoral degree in regulatory science in the nation.
Programs
Each of our interdisciplinary programs provides the intensive, hands-on learning and access to experts that build your knowledge, your network and your career.
Masters Degrees
• MS in Regulatory Science
• MS in Medical Product Quality
• MS in Management of Drug Development
• MS in Clinical Trial Management
• MS in Regulatory Management (Post Doctoral)
Graduate Certificates
• Medical Product Quality
• Clinical Research Design And Management
• Patient and Product Safety
• Preclinical Drug Development
• Regulatory And Clinical Affairs
Doctorate in Regulatory Science
“I chose USC because of the curriculum, industry standing and alumni network. The alumni are from all over the world – they have gone on to achieve big things through the program. The guest lecturers are all industry professionals who come and share the knowledge – all of this I find very helpful in terms of industry immersion.”
— Nabeela Jahangeer MS in Regulatory Science
‘24
Masters Programs
MS in Regulatory Science
The Regulatory Science master’s degree is for students in biological, pharmaceutical, biomedical sciences, biomedical engineering, and related fields. The program provides advanced knowledge of global regulations and quality practices in the biotechnology, pharmaceutical, and medical device industries. Students gain an understanding of blending science, regulation, and business to develop healthcare products. Through real-world projects, they develop practical tools to address challenges in regulatory, quality, and clinical sciences while navigating an evolving industry.
NEW!
MS in Clinical Trial Management
Introduced in 2024, the STEMdesignated Clinical Trial Management program enhances students’ understanding of the biopharmaceutical industry, focusing on clinical trial research. The program equips students with the skills for roles in pharmacy, medicine, healthcare, and biotechnology, with a focus on clinical trial management. It provides a comprehensive understanding of conducting clinical trials, covering topics like medical product regulation, project management, safety, ethics, and clinical trial writing.
MS in Management of Drug Development
The Management of Drug Development program is for students with a background in preclinical biological and pharmaceutical science. It prepares entry- and midlevel scientists for professional practice in translational research, focusing on the transition between early-stage drug discovery and clinical development. This program teaches students to design, evaluate, and optimize drug development strategies from discovery to marketing. Additional courses may focus on the strategic, policy, and regulatory aspects of drug development.
MS in Medical Product Quality
The Medical Product Quality degree is for students with a background in biological, pharmaceutical, biomedical sciences, and biomedical engineering. The program trains students in the theory behind current and future regulations impacting product quality and provides practical tools for industry careers. Students learn about regulations ensuring the quality of drugs, biologics, and medical devices in the US and internationally. They gain knowledge to apply in medical product development and manufacturing, while understanding the principles needed to interpret and implement quality practices and systems.
What is STEM?
STEM designated programs provide interdisciplinary technical and mathematical skills, as well as the business acumen needed to help solve complex business issues and help navigate the future of business.
STEM designated degree programs are designated by the Department of Homeland Security. F-1 students can apply for a 24-month OPT Extension if they:
• Receive a STEM degree
• Are employed by employers enrolled in the E-Verify system
• Have received an initial approval of Post-Completion Optional Practical Training (OPT) employment authorization related to such a degree
Learn more about STEM at USC, visit ois.usc.edu
“If you are an international student looking for diversified, uniquely tailored program to prepare you for any position that industry can offer, the best one-stop destination is our program here at USC.”
Post-Doctoral Masters Program
MS in Regulatory Management
The Master of Science in Regulatory Management program equips postdoctoral scientists and clinicians with the skills needed to lead in regulatory and clinical research. It addresses the need for advanced professionals who can provide strategic planning for product development and evaluate clinical studies, as doctoral programs often overlook these industryrelated topics. The curriculum fosters skills for team-based work, project management, and biomedical product development. Students receive advanced training in regulatory areas related to pharmaceuticals, medical devices, and clinical research, along with business and management knowledge.
“The program has provided me with a comprehensive understanding of the regulatory landscape, which has been invaluable in my role as a Health Economics & Outcomes Research (HEOR) fellow. Key skills such as regulatory strategy development, global market access, and insights into clinical trial design from a regulatory perspective have greatly enhanced my ability to collaborate cross-functionally and contribute to product value earlier in their life cycle.”
— Michelle Zhang , PharmD MS Regulatory Management ‘25 Fellow, Bristol Myers Squibb
Graduate Certificates
Our 12 unit graduate certificates are designed to increase your knowledge in certain areas key to medical product development. About four courses in length, each graduate certificate can stand alone as a true graduate endpoint or can be rolled forward after completion into the master’s or doctoral program.
Medical Product Quality
Designed for students with a background in biological, pharmaceutical and biomedical sciences and biomedical engineering who seek to expand their expertise in the thriving sector of industry that oversees quality assurance and quality control.
Clinical Research Design and Management
An ideal training program for individuals interested in clinical research, either at a clinical site or in a medical products company.
Patient and Product Safety
Prepares risk managers and pharmacovigilence experts for professional careers where medical products and facilities have high risks that need to be anticipated and controlled.
Preclinical Drug Development
Designed to provide advanced training for individuals interested in preclinical aspects of translational medicine and associated research.
Regulatory and Clinical Affairs
Acquaints individuals with the world of medical product regulation, and prepares them for roles in regulatory and quality aspects of medical product development.
12
Doctorate in Regulatory Science
In 2008, USC launched the nation’s first professional Doctor in Regulatory Science (DRSc), which gives mid-career professionals advanced training for global careers in both government and industry settings as well as the more traditional PhD trajectory of scholarly and academic roles.
Strong candidates are full-time working professionals with 10 to 15 years of experience in the regulated product industry with several years of experience managing or directing regulatory or quality departments.
Curriculum
• Foundational courses in Regulatory Science (minimum 15 units)
• Product Lifecycle Strategy (minimum 8 units)
• Project and Personnel Management (minimum 8 units)
• Global Regulatory Strategy and Policy (minimum 8 units)
• Research and dissertation preparation and completion (10+ units)
Length
The doctoral degree will typically be completed within 5 years of entry from the beginning of the program.
Admissions
Applications are accepted every two years starting in August of an odd year with a priority deadline of February 1 and final deadline of March 1 of an even year. Scan the QR code for more Admissions information.
Examples of Published Dissertations
Dr. Eugene Babcock, Evaluation of FDASponsor Formal Meetings on Development of Cellular and Gene Therapies: A Survey of Industry Views
Dr. Lori Alquier, Regulatory Harmonization in a Resource-Limited Setting: The World Health Organization Collaborative Procedure for Accelerated Registration
Dr. Carolyn Wright, Using Telemetry to Ensure Safe and Reliable Medical Device Operation: Experience with Defibrillators and Infusion Pumps
Dr. Martinus Koning-Bastiaan, Institutional review board implementation of the single IRB model for multicenter clinical trials
Dr. Duane Mauzey, Current Practices in Pharmaceutical Container Closure Development
Dr. Ellen Whalen, Clinical Trials Driven by Investigator-Sponsors: GCP Compliance With or Without Previous Industry Sponsorship
“Regulatory science is not onedimensional. It demands that you think outside the box to solve really novel and complex problems - over and over – and never quite the same problemwhile working with many across industry, government agencies, the medical community and patient communities, and who rarely agree on much of anything.”
— Neal E. Storm, DRSc ‘13 and MS ‘05
Director, Global Regulatory Affairs, Amgen
Admissions
To apply to our master of science or graduate certificate programs, you must:
Have completed a bachelor’s degree with a minimum grade point average (GPA) of 3.0 from an accredited college or university.
Submit two letters of recommendation from professionals or professors familiar with your capabilities and achievements.
Submit your most up-to-date resume.
Submit a personal statement that addresses your interest in the degree.
We welcome students from all backgrounds—no science degree required. While basic biology and chemistry knowledge is helpful, it’s not mandatory. Our programs equip students from diverse fields, including science, business, engineering, communication, law, and healthcare, for careers in regulatory affairs.
Scan the QR code to apply today!
International Students
English Proficiency
If your bachelor’s degree was earned in a non-English speaking country and you are not a U.S. citizen or permanent resident, you need to submit scores from an official TOEFL (Test of English as a Foreign Language) or IELTS (International English Language Testing System).
Please note that even if you are from an English-speaking country, you may still need to submit scores. We require that you have verification of the following scores within two years of your intended enrollment:
• An Internet Based TOEFL (iBT) score of 100 with no less than 20 on each subscore; or
• An IELTS of 7 with no less than 6 on each band score.
If your native language is English and/or you have a bachelor’s degree from a U.S. college or university, you are exempt from this examination. If you have questions about departmental requirements for the TOEFL, please contact regsci@usc.edu.
Flexible and Individualized
Regulatory and quality sciences offer diverse career paths, and our programs are designed to match that versatility. We emphasize flexibility and customization, ensuring you can balance your education with your professional and personal commitments.
You set your own pace—taking as many or as few classes as you need, when and where it works best for you. Choose from weekend, evening, online, classroom, or blended formats. Our intentionally small class sizes foster meaningful connections, collaboration, and networking.
Not ready to commit to a full graduate program? You can take individual courses without enrolling. If you later decide to pursue a certificate or master’s degree, your completed coursework will count toward your program requirements. And as your career evolves, you can return to earn your doctorate.
We take a personalized approach, supporting you in crafting a career path that aligns with your unique goals. Through specialized training, internship opportunities, and partnerships with industry and government, you’ll gain hands-on experience that sets you apart.
Whether you’re a working professional, exploring a gap-year opportunity, or pursuing full-time studies, we have a program tailored for you!
Limited Status Enrollment
Prospective students have the option to enroll in one or two courses as limited status students before formally applying to our program. This unique opportunity allows individuals to explore whether pursuing a Graduate Certificate, Master’s, or DRSc degree in Regulatory Science aligns with their goals. Limited status students may complete up to 6 units toward a Graduate Certificate or 12 units toward an MS/DRSc degree prior to applying and being admitted to the program. Enrollment as a limited status student does not guarantee admission to any degree program at USC.
Contact regsci@usc.edu
Distance Learning Option
Most courses are available to domestic students living more than 50 miles from the USC Health Sciences campus through synchronous Zoom sessions. Distance learners attend the same classes, engage in group projects, and interact with on-site students.
Note: F1 Visa students must attend classes in person during the Fall and Spring terms to maintain visa status. In the summer, F1 students are expected to be on-site for in-person attendance.
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Trojan Voices
“Prior to USC, I worked at the Taiwan FDA as a reviewer of medical devices. I got my first master’s degree in biomedical engineering, so with the MS in regulatory science from USC, I have gained the bigger picture — not just of medical devices but also pharmaceuticals and biologics.”
— Eric Lee Founder & CEO at Promise Biomedical, Inc.
MS Regulatory Science ‘19
“Our regulatory science classes are very interactive, and the faculty provide opportunities for us to enhance our experience with industry-oriented knowledge so we can end up with great jobs.”
— Amoolya Girish Senior Business Process Improvement Analyst at Medtronic Graduate Certificate in Medical Product Quality ‘19
“The faculty are very caring, and they help you along the road with a lot of advice and point you to new opportunities. I’ve presented my research results at multiple national conferences. ”
— Nora Zhu Senior Medical Writer at Genentech
MS Management of Drug Development ‘19
Akshata Kedar, MS Regulatory Science ‘24, wearing the graduation cap she handcrafted at the USC Mann Commencement in May 2024
