» Master of Science in Regulatory Affairs

The Master of Science of Regulatory Affairs (MSRA) is a 4-semester hybrid program that provides advanced didactic education and experiential simulation training in both an online and in-person format to help professionals advance as regulatory affairs experts and leaders. 

Regulatory affairs courses within this program will provide you with the knowledge and skills you need to effectively manage the regulatory process.  From discovery to commercialization, the program will cover the steps that are required to bring a medical product to market, both in the U.S. and around the globe.  Graduate courses address critical regulatory issues affecting all of the stages and processes in regulatory affairs.

The MSRA offers two tracks:
  • Biopharmaceutical 
  • Medical Devices

Graduates of the program can pursue a variety of career opportunities in the pharmaceutical, biotech and medical device industry, regulatory agencies, contract research organizations, consulting firms, among other organizations. 

The School of Pharmacy is located on Chapman’s Rinker Health Sciences Campus, in beautiful Irvine, California. Our location in Orange County provides unique opportunities for students to network with numerous nearby health care organizations and companies. Orange County is the #1 county in the U.S. with the number of employees in the health field and #2 for the number of medical equipment and supplies manufacturing establishments (U.S. Bureau of Labor Statistics). There are a substantial number of regulatory affairs positions and job opportunities in Orange County and the surrounding area.

 

How Can I Learn More about the MSRA program? 


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Admission and Application Information

Application Deadlines 

Fall 2020 - Semester begins August 31, 2020  

Apply to MS in Regulatory Affairs Program for Fall 2020 through the Chapman University Graduate Application.
  • June 1, 2020             Priority Deadline
  • June 30, 2020           Regular Deadline
*Applications submitted after the deadline will be reviewed on a space-available basis.

Spring 2021 - Semester begins February 1, 2021 

Spring 2021 applicants will apply through PharmGrad. The PharmGrad application portal will open in late August for Spring 2021 admissions. 

  • November 1, 2020     Priority Deadline
  • November 30, 2020   Regular Deadline
*Applications submitted after the deadline will be reviewed on a space-available basis.

 

How to Apply  

Our Graduate Application is available here.
Application Requirements: 

  • A bachelor’s degree from a regionally accredited university or college, or an accredited or government-approved international university in one of the following subjects:
    • Sciences, pharmacy, medicine, nursing, dentistry, or related areas
    • Law, business or related areas
  • Applicants with a bachelor's degree in other areas will be considered if the applicant
    demonstrates work experience and excellent achievements related to Regulatory
    Affairs. 
  • Preferred applicants have a cumulative GPA of 3.0 or higher.
  • Two letters of recommendation from individuals familiar with applicant’s academic abilities.|
  • A copy of an official transcript from the bachelor's degree-granting institution
  • A resume or curriculum vitae including relevant experience.
  • A personal statement of approximately 500 words which includes:
    • Your interest in the MSRA program at Chapman University
    • Your research goals
    • Your career goals
    • Your professional, academic, research, and extracurricular achievements

 

Additional Information for International Students 

  • Transcripts – Applicants submitting transcripts from foreign universities must submit transcripts in the native language as well as an English translation. 
  • English Proficiency Exam – International applicants whose native language is not English must submit results of the CAE, TOEFL, IELTS, or PTEA.

    English proficiency minimum score requirement must be met before an application will be considered.

    Minimum Score Requirements
      • CAE = 180
      • IELTS = 6.5
      • PTEA = 53
      • TOEFL = 550 (paper–based) or 80 (internet–based).
        • Chapman University School of Pharmacy school code for TOEFL is 4047

    Applicants with low English proficiency score must retake exam to reach minimum requirement before submitting application.

    • Unofficial English Proficiency exam results submitted with application must include Student Test ID Number.
    • Student must notify test agency to allow Chapman University access official score.
  • An English proficiency examination is not required from international applicants with a bachelor's degree or higher from a university in the United States or in another country where English is the primary or official language. 

 

Ways to Learn More: 

If you have any questions, please contact intladmit@chapman.edu 

Curriculum

The Master of Science in Regulatory Affairs (MSRA) degree requires completion of at least 30 credits. These include 18 credits of core courses, at least 9 credits of elective courses, and 3 credits of thesis or capstone project 

The MSRA program has two tracks: Biopharmaceutical and Medical Device 

A program of study is developed individually in consultation with the student's mentor and is designed to ensure expertise in the student’s principal field. This will present students with the opportunity, under the supervision of the program advisor, to tailor their academic program to prepare them for the career path of their choice. 

Biopharmaceutical Track 

Core Courses (18 credits) 

PHS 625 

US Regulatory Framework. FDA Regulatory Pathways and Options, 

3 

PHS 633 

Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation 

3 

PHS 635 

Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements 

3 

PHS 636 

US New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations 

3 

PHS 637 

Biomedical Products Marketing, Pricing and Reimbursement 

3 

PHS 640 

US Nonclinical and Clinical Regulation of Biomedical Products 

3 

Elective Courses (minimum 9 credits) 

PHS 634 

Global Regulatory Affairs 

3 

PHS 638 

Medical Devices Applications, Software and Digital Health Applications: Quality Assurance and Post-Marketing Requirements 

3 

PHS 639 

Medical Devices Applications, Software and Digital Health Applications: Pre-Marketing Regulation 

3 

PHS 602 

Drug Discovery and Development 

3 

PHS 612 

Advanced Principles of Drug Action 

4 

PHS 614 

Biologics 

2 

PHS 615 

Pharmacogenomics and Pharmacogenetics 

2 

PHS 621 

Introduction to Pharmaceutical Manufacturing Process 

3 

PHS 631 

Medical Diagnostics 

3 

PHS 632 

Medical Devices 

3 

PHS 651 

Quality System for Development and Manufacturing Drugs 

3 

PHS 661 

Biomedical Market Access 

3 

PHS 662 

Economic Evaluation of Health Care Services and Products 

3 

PHS 690 

Internship  

3 

PHS 701 

Research  

1-3 

PHS 702 

Research Rotations

1 

Thesis or Non-Thesis Option (3 credits) 
One of the following

PHS 696 

Capstone 

3 

PHS 698 

Thesis 

3 

Medical Device Track 

Core Courses (18 credits) 

PHS 625 

US Regulatory Framework. FDA Regulatory Pathways and Options 

3 

PHS 634 

Global Regulatory Affairs 

3 

PHS 637 

Biomedical Products Marketing, Pricing and Reimbursement 

3 

PHS 638 

Medical Devices Applications, Software and Digital Health Applications: Quality Assurance and Post-Marketing Requirements 

3 

PHS 639 

Medical Devices Applications, Software and Digital Health Applications: Pre-Marketing Regulation 

3 

PHS 640 

US Nonclinical and Clinical Regulation of Biomedical Products 

 

Elective Courses (minimum 9 credits) 

PHS 633 

Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation 

3 

PHS 635 

Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements 

3 

PHS 636 

US New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations 

3 

PHS 602 

Drug Discovery and Development 

3 

PHS 612 

Advanced Principles of Drug Action 

4 

PHS 614 

Biologics 

2 

PHS 615 

Pharmacogenomics and Pharmacogenetics 

2 

PHS 621 

Introduction to Pharmaceutical Manufacturing Process 

3 

PHS 631 

Medical Diagnostics 

3 

PHS 632 

Medical Devices 

3 

PHS 651 

Quality System for Development and Manufacturing Drugs 

3 

PHS 661 

Biomedical Market Access 

3 

PHS 662 

Economic Evaluation of Health Care Services and Products 

3 

PHS 690 

Internship  

3 

PHS 701 

Research  

1-3 

PHS 702 

Research Methods 

1 

Thesis or Non-Thesis Option (3 credits)
One of the following

PHS 696 

Capstone 

3 

PHS 698 

Thesis  

3 

 

M.S. in Regulatory Affairs Program Learning Outcomes 

  1. Expresses foundational knowledge of the elements of the regulatory affairs sciences, including current research literature, policies and procedures, and methodology.
  2. Understands regulatory affairs sciences by exploring and applying new ideas to current research.
  3. Effectively communicate scientific principles, ideas, and research results with different audiences at an appropriate level. 

 

Why Choose CUSP?

CUSP will provide students with a solid foundation in an integrated and interdisciplinary program within the regulatory affairs science and practice that combines: 

  • A comprehensive education and training to include strong foundational knowledge, current practices and ethics related to regulatory affairs. 
  • Leadership, innovation and entrepreneurship in patient regulatory affairs through didactic course work, simulation and active-learning internships 
  • Course work and simulation that broadens the trainees’ background to enhance career opportunities in regulatory affairs 
  • The School of Pharmacy's location in Irvine, Orange County, CA, provides unique opportunities for students to network with nearby medical device and pharmaceutical companies health care organizations. Orange County is a hub for the medical device and pharmaceutical industry, and health care organizations. Orange County is the 1st US county by the number of employees and 2nd by the number of medical equipment and supplies manufacturing establishments (US Bureau of Labor Statistics). There is a substantial number of regulatory affairs positions and job openings in Orange, California and the US 
  • Ranked #125 out 399 top-tier universities in the U.S. according to U.S. News & World Report, Chapman offers students personalized educational opportunities and a world-class faculty. 

Frequently Asked Questions (FAQ)

What are the career opportunities in regulatory affairs? 

There are significant career opportunities with the medical device, biopharmaceutical and health sciences industry; health care organizations, regulators, and other organizations requiring qualified specialists in regulatory affairs areas in Orange County, California and nationwide. 

Orange County is the 1st US county by number of employees and 2nd by number of medical equipment and supplies manufacturing establishments; and 13th by number of employees and 3rd by number of pharmaceutical and medicine manufacturing establishments (US Bureau of Labor Statistics) 

 

Does MS program require accreditation? 

No, there are no requirements for accreditation, certification, or licensing associated with the MSRA degree. Chapman University is accredited by the Western Association of Schools and Colleges (WASC) Accrediting Commission for Senior Colleges and Universities. 

 

What are the admission requirements? 

 

I do not have a bachelor’s degree in sciences, pharmacy, medicine, nursing, dentistry, law, or business. Can I still apply for this program? 

  • Applicants with a bachelor's degree in other areas will be considered if the applicant demonstrates work experience and excellent achievements related to Regulatory Affairs.

 

When can I enroll in the program? 

Applications are accepted for Fall and Spring semesters. 

 

Can I transfer from another program into the Chapman’s MSRA program? 

Transfers will be considered on a case-by-case basis if the curriculum requirements are met. 

 

What is the cost of the program? 

Please visit the Chapman University Tuition & Fees Information page for detailed information on Graduate Student Tuition at the Rinker Campus. 

  • There are 2 semesters in a year.
  • Textbooks are provided by the program for most classes.
  • Students are responsible for their own housing and other related expenses. 

 

Is there any financial assistance or tuition waiver plans? 

The University’s financial aid office can provide more comprehensive information on other forms of federal, state or private funding: (714) 997-6741 or gradfinaid@chapman.edu. 

 

Is the School of Pharmacy on the Chapman University Campus in Orange, CA? 

No. CUSP is located on the Harry and Diane Rinker Health Science Campus in Irvine, CA. The campus is 15 miles south of the Chapman Campus at 9401 Jeronimo Rd. CUSP is conveniently located 1.5 miles east of the I-5 Freeway, off of Alton Parkway, and within 2 miles of the Irvine Spectrum. 

 

Is there student housing near the School of  Pharmacy? 

Currently, there is no official Chapman student housing near CUSP. However, there are several apartment complexes within a few miles of the Rinker Health Science Irvine campus. A list of local apartment complexes, housing options, and other related resources is available on the CUSP Housing page 

 

Can I apply for the Pharm.D. program after I finish the MSRA program? 

Yes, students who have completed the MSRA degree can apply for the Pharm.D. program. They must fulfill the Pharm.D admission and pre-requisite requirements like all other applicants.