Regulatory Affairs

• Biopharmaceutical regulatory affairs—Learn how to apply statuses to the submission of marketing approval applications for both pharmaceutical and biological products to global regulatory agencies.
• Clinical research regulatory affairs—Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support biomedical product development.
• Global regulatory affairs–Study medical device product development and regulation across Canada and Europe; explore legal issues in international food, drug, and medical device regulation; and learn practical applications of regulatory strategy in the global marketplace. (Coming fall 2026)
• Medical device regulatory affairs—Learn how to apply statuses of the submission of marketing approval applications for medical device products to global regulatory agencies.
• Nonclinical Biomedical Product Regulation—Study the regulations applicable to biomedical product commercialization from preclinical development, quality, and manufacturing perspectives. (This concentration will no longer be offered after spring 2026.)
• Quality assurance and compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products. (This concentration will no longer be offered after spring 2026.)

• The online program provides flexibility and interactive experience for working professionals.
• Focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
• Participate in integrative experiential learning and/or the co-op program.
• Forge connections with our global network of alumni from some of the world’s most renowned companies, including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestle, Pepsico, and Coca-Cola.
• As a Northeastern University student and alumnus, you’ll have access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.
• The program has a science, technology, engineering, and mathematics (STEM) designation. This means international students can apply for a 24-month OPT STEM Extension to their 12-month Optional Practical Training (OPT) period, which allows them to work in the U.S. for up to 36 months after graduation. Non-U.S. students may take a certain number of online courses as approved by their advisor as long as they are enrolled in the required amount of on-ground coursework at our Boston campus per term. In these approved instances, the degree is STEM eligible.

Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:

Domestic Application Guidelines

International Application Guidelines*

_{*International deadlines are only applicable if the program is F1 compliant.}

• Online application

• Professional resumé

• Unofficial undergraduate transcripts; official transcripts required at the time of admission

  • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents from non-U.S. accredited post-secondary education institutions. (Review the FCE requirements by country.)

• English language proficiency proof. Students for whom English is not their primary language must submit one of the following:

  • Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date

  • TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores

• Other materials may be required