Regulatory Affairs

This program is offered under the written consent of the Minister of Colleges and Universities for the period from June 25, 2021 to June 28, 2026. Prospective students are responsible for satisfying themselves that the program and the degree will be appropriate to their needs (e.g., acceptable to potential employers, professional licensing bodies or other educational institutions).

• 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.)

• Students will have the opportunity to study biomedical product regulations directly applicable to commercialization of these products in Canada.
• 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.

This program is eligible for a Canadian Study Permit and Post Grad Work Permit (PGWP). For more information on studying in Canada-including how to apply for a study permit-please visit our Office of Global Services’ Canadian Campuses page.

Office of Global Services’ Canadian Campuses

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