Master of Science in Regulatory Affairs — Toronto
The Master of Science in Regulatory Affairs program is designed to produce graduates who are highly qualified to manage global regulatory processes for companies innovating and developing cutting-edge products in healthcare and food safety.
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Overview
The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring highly regulated products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs. This unique graduate degree is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.
Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a highly regulated product to market, both in the U.S. and around the globe.
Northeastern’s MS in Regulatory Affairs offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:
- Biopharmaceutical Regulatory Affairs
- Clinical Research Regulatory Affairs
- Medical Device Regulatory Affairs
- Nonclinical Biomedical Product Regulation
- Quality Assurance and Compliance
More Details
Unique Features
- Students will have the opportunity to study biomedical product regulations directly applicable to commercialization of these products in Canada.
- Students can focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
- Students will participate in integrative experiential learning and/or the cooperative education program as part of their course of study.
- Students will have the opportunity to 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.
Program Objectives
Successful completion of the MS-RA Program will enable students to:
- Gain the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment.
- Acquire the professional foundations necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, clinical research, and food safety.
- Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
- Refine your understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of drugs, biologics, medical devices, and food safety.
- Analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations.
Concentrations
- 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.
- Medical Device Regulatory Affairs—Learn how to apply statutes 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 pre-clinical development, quality, and manufacturing perspectives.
- Quality Assurance and Compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products.
Program Approval and Accreditation
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.
For International Students
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.
Experiential / Co-op Opportunities
Northeastern's signature experience-powered learning model has been at the heart of the university for more than a century. It combines world-class academics with professional practice, allowing you to acquire relevant, real-world skills you can immediately put into action in your current workplace.
This makes a Northeastern education a dynamic, transformative experience, giving you countless opportunities to grow as a professional and person.
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
General Requirements
| 2.00 | ||
| 5.00 | ||
| 5.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Note: Students may select RGA 6203 or RGA 6204, but not both.
Capstone
| 4.00 |
The remaining quarter hours may be completed by selecting a combination of a concentration and additional electives or selecting any courses listed in the concentrations and elective lists.
Elective Courses
General Electives
| 3.00 | 4.00 | |
| 2.00 | ||
| 3.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 2.00 |
Regulatory Affairs of Food
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 3.00 |
International Regulatory Affairs
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 4.00 |
Concentrations
Biopharmaceutical Regulatory Affairs
| 2.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Clinical Research Regulatory Affairs
| 4.00 | ||
| 4.00 |
Choose one of the following:
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Medical Device Regulatory Affairs
| 2.00 | ||
| 4.00 | ||
| 4.00 |
Choose one from the following:
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 4.00 |
Nonclinical Biomedical Product Regulation
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Quality Assurance and Compliance
Complete one of the following:
| 2.00 | ||
| 2.00 | ||
| 3.00 |
Complete the following:
| 4.00 | ||
| 4.00 | ||
| 2.00 |
Choose from the following to reach 16 quarter hours:
| 4.00 | ||
| 4.00 | ||
| 3.00 |
Now Let's Talk Admissions
You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.
Application Requirements
- Online application
- Unofficial undergraduate/graduate transcripts (you can submit official transcripts from all colleges/universities attended 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.)
- Statement of purpose that should include career goals and expected outcomes and benefits from the program
- Recent professional resumé listing detailed position responsibilities
- Two confidential letters of recommendation
As an international student, there are a number of documents you need to study in Canada.
- Valid passport: applications can take up to three months (or longer), so apply as soon as possible
- Study permit: all international students in programs longer than six months need a valid study permit
- Temporary Resident Visa (TRV) & Electronic Travel Authorization (eTA)
- Only citizens of certain countries require a TRV
- If you are from a TRV-exempt country, you may need to apply for an eTA before you can travel to Canada
You are responsible for maintaining your immigration status and complying with immigration regulations while you are in Canada.
International Requirements
Are You an International Student? Find out what additional documents are required to apply.
Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.
Financing Requirements
International Students Tuition rate for International (Non-Canadian Resident): $45,450 CAD
How to Apply Learn more about the application process and requirements.
PlusOne
Your Head Start on a Master’s Degree
The PlusOne Accelerated Master’s Program provides motivated students with the opportunity to start earning their master’s degree while pursuing their undergraduate education. By completing the BS in Biotechnology, you can advance your learning by applying up to 16 earned semester hours (or up to 22.5 quarter hours) toward both your bachelor's and master’s degree, allowing you to receive your graduate degree one year sooner than you would with a traditional Master of Science in Regulatory Affairs program.
View the registrar’s website for program-specific information
Cost and Tuition
Application Deadlines
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.
Student Body Profile
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.