https://www.pacific.edu/pharmacy/academics/regulatory-science-ms
Programs Offered
Master of Science in Regulatory Science
Program Overview
The Master of Science in Regulatory Science (non-thesis) is 32 units and can be complete as quickly as 16 months (4 trimesters). It is designed to provide training in scientific and regulatory strategy to those who aim to pursue careers as regulatory scientists working on product development in Biotech, Pharma, the FDA and equivalent global regulatory agencies. Graduates of the MS in Regulatory Science program will be able to develop protocols, evaluate and enforce existing guidance's and support regulatory fillings as it relates the safety, efficacy, quality, and performance of FDA-regulated products. This MSRS program will have a STEM designation.
Admission Requirements
- A bachelor’s degree with a B average (GPA of 3.0) or higher is required in all upper-division coursework, including all official transcripts.
- The GRE® General Exam is required to determine an applicant’s readiness for graduate school. The minimum combined score for the Verbal and Quantitative sections is 298. The minimum Analytical score is 3.0. Scores can be no older than five years old. Applicants must submit an essay or personal statement focusing on career objectives and personal ideals. Grammar and writing skills are an important part of the evaluation. A cumulative GPA of 3.5 may qualify for GRE waiver request.
- Three letters of recommendation, no more than one year old.
All international applicants must meet the following requirements:
- International students who attended schools outside of the United States must submit an evaluation of their academic records. Additionally, transcripts must be reviewed by one of the following outside evaluation agencies: World Education Services (WES) or Educational Credential Evaluators (ECE). Please request a course-by-course evaluation that includes a grade point average (GPA) and have an official copy sent directly to the Office of Graduate Admission. Student transcripts need to be translated into English before an evaluation can be processed. Please check with the evaluation agency for details on specific document requirements.
- A Certification of Finances form with all required documents must be completed and sent with the application materials or upon notification of admission by PCSP.
- Proof of English proficiency is required of all applicants whose native/principal language of instruction is not English. This requirement can be met by minimum scores of 80 (iBT) or 550 (paper) on the Test of English as a Foreign Language (TOEFL) or 6.5 on the International English Language Testing System (IELTS) or 105 on Duolingo. Official test score reports are required and can be no older than two years old.
Master of Science in Regulatory Science
Students must complete a minimum of 32 units with a Pacific cumulative grade point average of 3.0 in order to earn the Master of Science degree in Regulatory Science.
| Requirements: | ||
| Regulatory Sciences in Drug Development | ||
| Biostatistics and Clinical Trial Design | ||
| Trends in Drug Design 3 | ||
| API: Synthesis & Characterization Specifications | ||
| Formulation: Science & Drug Development (Preformulation and Product Development) | ||
| Lifecycle Management | ||
| GxP's | ||
| Pharmaceutical Marketing and Project Management | ||
| Reg Sci: Product Specifications | ||
| Reg Sci for device and drug combination | ||
| eCTD (electronic Common Technical Document) | ||
| Internship/CapStone Project/Development of a model filing | ||
Learning Outcomes
This program is for individuals with a clear objective to cultivate a career in regulatory science in the pharmaceutical, biotech and drug device industries and those with an industry background desiring advanced education in regulatory science and/or management.
- Identify, Formulate & Solve Complex Scientific Problems.
- Conduct Appropriate Experimentation in Pure & Applied Research.
- Function in Multidisciplinary Teams.
- Recognize Ethical & Professional Responsibilities & Make Informed Judgments in Global, Economic, & Societal Contexts.
- Exhibit Behaviors Consistent with the Pharmaceutical Scientists Profession.
Master of Science in Regulatory Science Faculty
Vijay K. Tammara, Director, MS Regulatory Sciences, Clinical Professor, Pharmaceutical Sciences,, 2025, PhD, School of Pharmacy, Northeastern Louisiana University, Monroe, Louisiana, 1999.
