»Master of Science in Regulatory Affairs

Bachelor’s degree from a regionally accredited university or college, or an accredited or government-approved international university in one of the subjects listed below.

Bachelor’s degrees in other areas will be considered if the applicant demonstrates work experience and excellent achievements related to regulatory affairs.

• Sciences (e.g., biology, chemistry)
• Pharmacy
• Engineering
• Nursing
• Law
• Business or related areas

Additional Information for International Students

• 1. Official Transcripts from the bachelor's and master's degree-granting institution(s)
     Your application requires official academic transcripts/mark sheets from the university you earned your degree in both the original language and English.
     • If your university does not provide translations of your transcripts/mark sheets, you will need to have them translated.  Transcripts must be translated exactly line-by-line, word-for-word.
     • You must submit the official academic transcript/mark sheet and the official translation.
     • While unofficial copies of academic transcripts/mark sheets can be used to evaluate and review an application, official documents will be required upon acceptance.
  2. English Proficiency Exam – International applicants must demonstrate English proficiency by submitting official scores from an English language exam.
     
     Minimum score requirement must be met before an application will be considered. Applicants with low English proficiency score must retake exam to reach minimum requirement before submitting application. Proficiency scores are found here: International Application Requirements
     
     
     • Unofficial English Proficiency exam results submitted with the application must include a Student Test ID Number.
     • Students must notify the test agency to allow Chapman University access to the official score.
       
       
     •  An English proficiency examination is not required from international applicants with a bachelor's degree from a university:
       • regionally accredited in the United States, or
       • where the sole language of instruction is English

• International Application Requirements: https://www.chapman.edu/admission/graduate/international-students/how-to-apply.aspx
• International FAQs: https://www.chapman.edu/admission/graduate/international-students/frequently-asked-questions.aspx

If you are an international applicant and have any questions, please contact:gradadmit@chapman.edu. 

Want to Learn More about admission? Please contact the program office: gradpharmsci@chapman.edu.

The Master of Science in Regulatory Affairs requires the completion of a minimum of 30 credit hours, including 18 credits of core coursework and at least 12 credits of electives. The curriculum is designed to prepare students for roles in both the biopharmaceutical and medical device industries through simulations that mirror real-world regulatory affairs workflows and decision-making environments.

Core Courses (18 Credits)

• PHS 625: U.S. Regulatory Framework, FDA Regulatory Pathways, and Options
• PHS 633: Biologic and Biosimilar License Applications: Pre-Marketing Regulation
• PHS 635: Biologic and Biosimilar License Applications: Cell and Gene Therapy and Post-Marketing Requirements
• PHS 637: Biomedical Products Marketing, Pricing, and Reimbursement
• PHS 638: Medical Device, Software, and Digital Health Applications: Quality and Post-Marketing Requirements
• PHS 640: U.S. Nonclinical and Clinical Regulation of Biomedical Products

Elective Courses (12 Credits)

• PHS 634: Global Regulatory Affairs
• PHS 636: U.S. New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations
• PHS 639: Medical Devices Applications: Pre-Marketing Regulation
• One additional elective course

 

Students should consider the following expenses as they financially prepare for their graduate school experience. Since actual student expenses vary, these estimates below offer broad guidelines for planning and may not reflect all of the actual costs.

Have questions? The Graduate Financial Aid Office can assist students in finding resources to meet their financial needs. For inquiries, please contact the Office via email or by phone at (714) 628-2730.

Tuition and Fees

Living Expenses – Including room/board, transportation, personal expenses, etc…

• Health Insurance – REQUIRED 

• • Please see Tuition and Fees 

• • (Can be waived if student already has health insurance) 

Tuition costs $1,800 per credit hour for the 2026/2027 academic year.

MS in Regulatory Affairs Program Learning Outcomes

1. Understand Global Regulatory Systems and Product Development
   Gain working knowledge of U.S. and international regulatory frameworks across the product life cycle, from development to post-market. Apply this understanding to ensure compliance in the pharmaceutical and medical device sectors.
2. Communicate and Prepare Regulatory Submissions Effectively
   Develop skills to create accurate, well-structured regulatory documents. Communicate strategy and scientific rationale clearly to internal teams and health authorities.
3. Lead Ethical and Strategic Regulatory Decisions
   Apply ethical reasoning and strategic thinking in regulatory roles. Support organizational goals by guiding decisions that prioritize patient safety and innovation.