Regulatory Science, Master of Science

MS in Regulatory Science

There are thousands of foods, drugs, biologics, devices, and other medical products currently in the global biotechnology marketplace and many in the development pipeline. These products and devices require regulatory professionals to ensure compliance with the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the Environmental Protection Agency, the Alcohol and Tobacco Tax and Trade Bureau rules and regulations, and/or their equivalents in other countries. 

The Master of Science in Regulatory Science program prepares students to become leaders in the regulatory field by helping them to become versed subject-matter collaborators in the U.S. and globally. The curriculum is designed to prepare the next generation of interdisciplinary professionals to address current and future challenges. Students will have the opportunity to tailor their studies either in the food or medical products and processes domain with curated core and elective courses.

The program is designed with a student-centered approach to ensure that students' educational experience is as enriching and supportive as possible. As a 100% online program, it is designed to fit seamlessly into busy schedules and gives students the opportunity to learn from exemplary biotech professionals and advance their education without disrupting their career.   

Admissions Criteria for All Advanced Academic Programs 

PROGRAM-SPECIFIC REQUIREMENTS

In addition to the materials and credentials required for all programs, the MS in Regulatory Science program requires an undergraduate degree in the natural sciences or engineering, with a grade point average of at least a 3.0 on a 4.0 scale. Meeting the minimum GPA requirement does not guarantee admission. Additional requirements:

• Resume
• Statement of Purpose: Please provide a statement, up to one page in length, describing your personal background and/or a part of your life experience that has shaped you or your goals. Feel free to elaborate on personal challenges and opportunities that have influenced your decision to pursue a graduate degree at Johns Hopkins.
• Required Courses:
  • One semester of biochemistry
  • One semester of any of the following: cell biology, molecular biology, physiology, pharmacology, genetics, microbiology, food science, immunology, biomedical engineering, pharmacovigilance

Program Requirements

Students in the MS in Regulatory Science program complete 10 courses:

• Four required core courses
• Three customizable courses
• Three elective courses

Course List

Code	Title	Credits
Core Courses - Required:		16
AS.410.649	Introduction to Regulatory Affairs - Medical Products
AS.410.676	Food And Drug Law
AS.410.679	Practicum in Regulatory Science
AS.410.701	Introduction to Regulatory Affairs-Food, Cosmetics, Alcohol and Tobacco
Core Customizable Courses:		12
Select three of the following:
AS.410.651	Clinical Development of Drugs and Biologics
AS.410.715	Medical Device Regulation
AS.410.675	Global Medical Products Regulation
AS.410.683	Introduction to cGMP Compliance
AS.410.686	Food Production cGMPs: Regulations, Standards and Emerging Controls
AS.410.674	Food and Bioprocess Microbiology
AS.410.718	Developing and Auditing Food Safety Programs
AS.410.739	Traceability Outbreaks and Recalls
Electives		12
Select three of the following:
AS.410.727	Regulatory Strategies in Biopharmaceuticals
AS.410.648	Clinical Trial Design and Conduct
AS.410.673	Biological Processes in Regulatory Affairs
AS.410.717	Risk Assessment and Management
AS.410.694	FDA Premarket Applications
AS.410.702	AI and Software Regulation in Biomedical Science
AS.410.716	Applied Toxicology in Biotechnology
AS.410.719	Regulation of Dietary Supplements
AS.410.721	Cannabis Beverages and Edibles: Safety, Standards and Compliance
Total Credits		40

Learning Outcomes

Graduates of the MS in Regulatory Science program will be equipped to engage with the following areas detailed below.

• Interpret and apply U.S. and global regulatory frameworks governing food, drugs, biologics, medical devices, and related products across the full product lifecycle.
• Analyze Food and Drug Law and related statutes to ensure compliant product development, labeling, manufacturing, and post-market oversight.
• Conduct evidence-based risk assessments incorporating microbiology, toxicology, clinical data, and regulatory science principles to support safety and approval decisions.
• Design, implement, and evaluate GMP/cGMP and safety management systems that meet regulatory requirements across food and medical products sectors.
• Develop regulatory strategy documents that guide product approval, commercialization, surveillance, and enforcement response.
• Manage regulatory activities from research and development through manufacturing, labeling, market authorization, and post-market monitoring.
• Communicate regulatory science effectively in technical, legal, and policy environments and collaborate within multidisciplinary regulatory teams.
• Apply ethical principles, regulatory governance, and leadership skills to protect public health and ensure regulatory integrity.