Doctor of Regulatory Science (DRSc) Degree | Curriculum and Requirements

The USC Doctorate of Regulatory Science degree requires satisfactory completion of 64 units beyond the baccalaureate degree, 4 of which are devoted to the writing of a thesis. Students with a master’s degree may receive partial credit for coursework taken for a previous graduate degree.

Program Structure

The program is organized as a series of modules with different foci. Students must take a minimum number of credits in each focus, and then can add additional elective courses from a broader portfolio of appropriate offerings taught in the School of Pharmacy and other Schools in the University. We encourage students to take at least a few courses in other Schools so that they develop a broader perspective and interdisciplinary appreciation, but aim to offer a sufficient richness of courses to meet the needs of our doctoral students within our School, should timetabling issues preclude the option of courses outside of the School of Pharmacy that might be given only during the normal working week.

Foundational courses in Regulatory Science (minimum 15 units): These form the base and would typically be composed of core courses to the MS program or equivalent courses from graduate programs elsewhere.

Product Lifecycle Strategy (minimum 8 units): A number of courses in this grouping are offered by the School of Pharmacy, either through Regulatory Science or through the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics and Policy. Students are also encouraged to take courses outside of the Pharmacy School when more specialized courses fit their personal research or professional plans.

Project and Personnel Management (minimum 8 units): Relevant courses are available through the Regulatory Science program. Alternative options are available from other University of Southern California Schools including the Marshall School of Business and School of Policy, Planning and Development.

Global Regulatory Strategy and Policy (minimum 8 units): Globally-oriented courses. Two of these courses take students abroad, so that participants can meet global regulatory leaders and study global health-care systems in a challenging and immersive cultural experience.

Research and dissertation preparation and completion (10+ units): All students will complete a professional dissertation that starts with at least one course in research design. We currently offer two such courses, one in basic/social sciences methodology and the other in clinical study methodology. Students must take at least one of these courses in preparation for their dissertation research. Research will be concerned with specific aspects of regulatory science, such as policy, administration, best practices or ethics. The students will work in subgroups of 3-4 as they develop their research projects, and will meet regularly in this group with their advisory team to discuss progress and challenges. Each student will be mentored by two identified advisors, one from university graduate faculty and the other an industry or government supervisor/mentor who normally is appointed as an adjunct in the School. Each student must produce and defend an independent dissertation as a requirement of graduation.

Graduation Requirements

Students will take a written examination after they complete the foundational courses. The doctoral degree will typically be completed within 5 years of entry from the beginning of the program. Students will be monitored throughout the program on a term by term basis to ensure that they maintain an appropriately high GPA of 3.0 or above; failure to maintain this GPA for two consecutive terms will normally result in dismissal from the program. By the end of the program, we anticipate that the students will not only have a mature and detailed understanding of the regulations underlying global regulatory affairs, but a strong understanding of managerial tools, policy setting mechanisms and strategic decision making in the medical products and foods sectors. In addition, they should understand the basic tenets of research and analysis as evidenced by their thesis submission, which will be typically focused on policy, best-practices or organizational management. Graduation depends upon the successful completion of coursework with a minimum GPA of 3.0, a qualifying examination defense and the successful defense of a dissertation.

Admission Requirements

Applicants for admission to the DRSc program are expected to have at least a baccalaureate degree from an accredited college or university. A minimum GPA of 3.0 (A = 4.0) is required. Applicants must have earned a minimum cumulative 3.0 GPA in the 400- and 500-level required courses. At least three letters of reference, an autobiographical statement of purpose and a current resume are required. Applicants’ leadership potential, previous academic record, clinical experiences and professional accomplishments will also be considered.

Application Procedure

Applications are accepted every two years starting in August of an odd year with a deadline of February 1 of an even year. For example the application for the 2018 cohort opened in August of 2017 and closed on February 1, 2018. For consideration, all application materials must be received by the February 1 deadline. Application requirements include:

  1. USC Online Graduate Application
  2. Transcripts from all colleges/universities attended
  3. Three letters of recommendation
  4. Industry experience (resume)
  5. Statement of purpose
  6. International students only: TOEFL (minimum 100) or IELTS (minimum 7). A Master’s degree from a US institution does not waive this requirement.

More detailed application information can be found on the DRSc Admissions Page.