»Master of Science in Regulatory Affairs

Students in the Master of Science in Regulatory Affairs program will select one of two tracks:

• A Biopharmaceutical track, which focuses on bringing drugs, cell and gene therapies and similar products to market. 
• A Medical Device track, which addresses issues encountered by medical device makers and developers of software and digital health applications.

Students in both tracks will complete six core classes and three electives, as well as a thesis or capstone project. 

Review the Academic Catalog 

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

• 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.

• 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.

• 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.

The MSRA program application opens in August one year prior to the fall term.

New students can enter during the fall term, which begins the last Monday of August.

Upcoming deadlines: 

• Priority consideration for Fall 2026 term: January 15, 2026

• Regular deadline for Fall 2026 term: June 30, 2026

Applications received after the deadline will be considered on a space-available basis.

Students entering Chapman’s Master of Science in Regulatory Affairs program must have a bachelor’s degree in one of the following subjects:

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

Degrees must be granted from a regionally accredited university or college or an accredited or government-approved international university, with a cumulative GPA of at least 3.0. 

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

Applicants must also provide two letters of recommendation, a resume or CV, official transcripts and an official statement of purpose.

In addition to the above, international students must provide:

• Official transcripts from the bachelor's and master's degree-granting institution(s). Your application requires official academic transcripts/mark sheets from the university where 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 transcripts/mark sheets and the official translations.
• While unofficial copies of academic transcripts/mark sheets can be used to evaluate and review an application, official documents will be required upon acceptance.
• English Proficiency Exam results. 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 scores must retake exams to reach minimum requirements before submitting an application. Minimum 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 grant Chapman University access to the official score.
    • An English proficiency examination is not required for 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

Learn About International Application Requirements 

Read FAQs for International Admission 

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

Students should consider the following expenses as they financially prepare for their graduate school experience. Since actual student expenses vary, the estimates 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 Fee Information
• Living Expenses (including room/board, transportation, personal expenses, etc.)
• Health Insurance – REQUIRED 
• Please review Chapman’s 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.