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. The Master of Science in Regulatory Science is an intensive, interdisciplinary program within the School of Pharmacy 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. You can also read an FDA article “Why You Should Care About Regulatory Science.”
Our programs are uniquely designed to produce graduates who can meet the growing need for a new generation of regulatory scientists working in the pharmaceutical, medical device and food safety industries. Job tracks include: quality systems and good manufacturing practices, regulatory affairs, risk management, clinical trials, preclinical science and more. Please review articles at Science and Nature.
Our curriculum provides a unique combination of in-class training and industry experience. The program offers six Graduate Certificate programs (12 units each), three Master’s degrees (32-36 units), and the Doctor of Regulatory Science degree (64 units). Core courses cover six areas: regulation of foods and medical products, quality assurance, clinical research, statistics, law, and business. Students are able to transfer credits from graduate work that they have done in the past towards their degree. Other credits can be taken from a list of our optional courses or from any area of interest relevant to regulatory science; these alternative courses must be approved.
USC Regulatory Science and Drug Development graduates are in great demand among top industry employers. Our graduates are now employed in industry, government, consulting and academia. Our alumni are now leaders in a profession designed to meet industry and governmental challenges in speeding up the delivery of medical advances to the people who need them, while ensuring that safety standards are met. The biomedical industry has grown rapidly, and this has fueled a large—and largely unmet—demand for regulatory professionals, both nationally and internationally. Our programs are uniquely designed to produce graduates who can meet this growing need for a new generation of regulatory scientists, formulation engineers, GMP experts and reimbursement specialists.
The Regulatory Science program is designed for participants with strong science or industry backgrounds. Preference will be given to candidates who have completed previous graduate study in science, engineering or business, although students with particularly strong undergraduate transcripts and leadership qualities will also be considered for admission.
Master’s and Graduate Certificate Programs: Applicants have the option to apply to any of the three terms: fall, spring, or summer. Applications can be submitted at any time, preferably at least three months before the beginning of the semester term. International students are strongly urged to apply to the fall semester.
Doctorate Program: We admit students every two years, and the next admission cycle will be for the fall 2022 semester. We invite you to take advantage of the application period to research the program and its potential, along with how you think the program will benefit you and your professional goals.
Prospective students may opt to enroll in a course or two as a limited student (“visiting” student) prior to applying/being accepted to our program. This is a unique opportunity which allows potential applicants to see if they would like to pursue a future Graduate Certificate, Master’s, or DRSc degree in Regulatory Science. Limited enrolled students should be aware that they are only allowed to take up to 12 units before applying and being admitted to the program.
The majority of our students work either part-time, full-time or as an intern. Our program offers students a professional advantage by having courses primarily on Fridays, Saturdays, and/or Sundays; occasionally courses will be held on the weekdays. Each course usually meets for a total of five days from 9:00am-5:00pm; the schedule varies from term to term. With this distinctive course set-up, most of our students are able to work and earn their degree simultaneously.
The time period to earn a degree depends on the individual and the degree program. The Regulatory Science program works to accommodate students within reason given the university’s administrative requirements.
- Graduate Certificate: The 12 unit program can easily be completed in two to four semesters.
- Master of Science: On average, most students obtain their degree within a year or two of enrollment, but three years may be needed if you take a single course each term. For participants without industry experience, the full-time MS program has four terms: three terms of coursework and one term of internship in industry or government. Part-time studies are possible and encouraged. Talk to our counselor to develop an individualized program that meets your special needs.
- Doctorate: On average, the program can be completed in 4 to 5 years with the final year devoted to research and writing your dissertation.
Although USC does not offer a PhD in Regulatory Science, similar to the PhD, the DRSc includes a research-based dissertation and bestows the title of “Doctor” on its recipients. The key difference between the degrees is that the research for the PhD is more “lab-based” and most students who receive the PhD are interested in an academic career path of teaching and research. The benefit of the DRSc is the potential of our graduates to work in both professional (government, industry) and scholarly/academic capacities.
Those who study with us by distance attend the same classes as students onsite and participate in group projects with their fellow students. The classes can be viewed in real time or on delay. In all respects, distance students pursue the same program as those onsite. We have successfully offered our distance program to people all over the US for more than 10 years.
The School of Pharmacy offers an innovative dual degree program for MS students currently enrolled in PharmD studies. In this dual program, twelve credits of coursework in the PharmD program are counted toward the requirements for the MS in Regulatory Science, which greatly shortens the coursework component. Students wishing to take the dual program should identify their interests early, because the program is best started at the end of the first or second year of studies. Contact the program coordinator if you are interested in the dual PharmD/MS or PhD/MS degree.
In general, institution funding is not available for professional degree programs but we encourage you to research various financial assistance options available. The USC School of Pharmacy is committed to helping all eligible students achieve their educational goals regardless of their economic status.
The following regulatory and quality science degrees are STEM designated:
- MS in Regulatory Science
- MS in Management of Drug Development
- MS in Medical Product Quality
International regulatory science students may also qualify for an Optional Practical Training (OPT) extension to their F-1 VISA after they complete the program. Read more about our STEM-Designated Programs here.