Certificate Programs in Regulatory Science

What is regulatory science?

Regulatory Science pertains to the regulatory and legal requirements of biomedical product development, and 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 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.”

What career paths are open in the fields of regulatory science and drug development?

Graduates of our programs are in great demand among industry, government, consulting, and academia. 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. The biomedical industry has grown rapidly, and this has fueled a large—and largely unmet—demand for regulatory professionals, both nationally and internationally. 

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.

What is included in the graduate-level curriculum?

Our curriculum provides a unique combination of in-class training and industry experience. The program offers five Graduate Certificate programs (12 units each), four Master’s degrees (32-36 units), one post-doctoral Master’s degree, 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. 

Am I eligible to apply to the program?

The Regulatory & Quality Sciences programs are 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.

What are your admission cycles?

Master’s and Graduate Certificate Programs: When applying to our program, applicants have the option to choose between three terms: fall, spring, or summer. To ensure consideration, applications must be submitted by the deadlines specified in the Admissions section for the program of interest. It is highly recommended that international students submit their application by the first deadline for each term.

Doctorate Program: We admit students every even-numbered year, with applications open during the odd year previous. For example, applications for the 2028 DRSc Cohort will open in August of the year 2027. 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.

Can I take a course or two before applying to see if the program is right for me?

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. Learn more about Limited Status Enrollment here.

Can I work while earning my regulatory science degree at the same time?

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 setup, most of our students are able to work and earn their degrees simultaneously.

How long will it typically take to earn a degree in regulatory science?

The time period for earning 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 advisor to develop an individualized course plan that meets your specific 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.

What is the difference between a doctorate and a PhD in regulatory science?

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.

Do you have distance learning courses available in your program?

The majority of our courses can be attended synchronously via zoom for domestic students who reside outside of 50 miles from the Health Sciences campus.

Those who study with us by distance attend the same classes as students onsite and participate in group projects with their fellow students. 

Please note all F-1 Visa students must attend class onsite during the Fall and Spring terms in order to maintain visa status. If taking courses during the summer, F-1 students are expected to remain onsite and attend class in person.

Do you offer a dual degree program with regulatory science?

USC Mann offers an innovative dual degree program for currently enrolled PharmD students who wish to pursue an MS in Regulatory Science. 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 must complete 25 course units by the end of the last semester of their PharmD program to complete the degree requirements for the dual degree. 

We recommend that PharmD students interested in applying to the dual PharmD/MS program be in at least their second professional year of study. Contact our office at regsci@usc.edu if you are interested in more information. 

Do you offer progressive degree program options?

Four of our MS degrees are eligible for ambitious students who would like to pursue a graduate degree concurrently with their bachelor’s degree. For full eligibility guidelines, please refer to this link.

What is the cost of tuition for the program?

To learn about the cost of tuition and fees, you can visit the USC Financial Aid “How Much Will My Education Cost?” page or check the USC Catalogue. Tuition is charged per unit for each academic year and is the same for both resident and non-resident students. A single course usually consists of 3 units. It’s important to note that tuition rates may change without prior notice. If you have questions about tuition, fees, or your financial aid summary, please contact the USC Financial Aid office.

Which programs are considered to be STEM?

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
• MS in Clinical Trial Management

International students may also qualify for an Optional Practical Training (OPT) 24-month Extension to their F-1 VISA after they complete a STEM program. Please contact the Office of International Services for detailed information and assistance on OPT.

I am a postdoctoral scholar at USC, how do I apply for admission to your program?

If you are a postdoctoral scholar at USC and want to apply for our program, you can apply online via the USC Graduate Admissions website. Our programs are listed under the “USC School of Pharmacy” section. Please ensure that your transcripts and test scores are sent to USC before the application deadline. It’s worth noting that only the first 12 (graduate) units taken through limited status enrollment can be applied toward a degree for postdoctoral scholars who plan to complete an academic program using their tuition remission benefits. Therefore, we advise you to consult with our program early on regarding course planning before taking the required courses toward a degree or certificate. For additional information on the Postdoctoral Tuition Remission Benefit, click here.

I am an international student, can I register for classes during the summer?

Yes, as long as you plan to remain in the U.S. for the summer term. In order to maintain visa status, international students must be registered full-time during the fall and spring semesters; summers are optional*. Many international students take this time to travel and/or visit their families. If international students opt to take summer courses, they must attend in person. We are not an online program and do not offer online classes. International students who fail to meet these requirements will have their I-20 terminated.

If you are participating in RSCI 596: CPT (Curricular Practical Training) during the summer, you can do your internship out of state, though not internationally.

To learn more, click here.

Please note: Students admitted in summer are required to enroll in a full course load during their first summer session.