RGA

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices — Toronto

The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program is designed to produce graduates who are highly qualified to manage global regulatory process for companies innovating and developing cutting-edge products in healthcare and food safety.

Take a quick look

We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.

01

Customize your plan

We work with you to map your path to your goal.

02

Learn from experience

From real-world case studies to employer-based projects, we prepare you to manage what comes next.

03

Choose your focus

Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.

04

Study anywhere, on your time

Part-time or full-time, we move at your speed, to get you where you’re going.

Enrollment

Full-Time, Part-Time

Entry Terms

Fall, Winter

Completion Time

12-18 months

F1 Visa Eligible

Yes

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 for Drugs, Biologics, and Medical Devices. 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 for Drugs, Biologics, and Medical Devices 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.

 

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.

Learn About Getting Real World Experience

Get Set with a Custom Course Plan

General Requirements

2.00
5.00
5.00
4.00
4.00
4.00

Note:  Students may select RGA 6203 or RGA 6204.

Capstone

4.00
 

Required Electives

Complete electives to meet the total required number of program quarter hours. One course must be chosen from each category below, and additional electives may come from those lists or the topics list.

Regulatory Operations

4.00
4.00
4.00
4.00
4.00
3.00
3.00

Regulatory Perspective: Product Development, Business, and Strategy

4.00
3.004.00
2.00
3.00
1.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
2.00
2.00

International Regulatory Affairs

4.00
4.00
4.00
4.00
4.00
4.00
4.00
2.00
2.00
4.00
4.00
4.00

Please Note: Prior to enrolling in COP 6940 Personal and Career Development (COP 6940), students must:

  • complete 20 credit hours in the current program of study
  • maintain a cumulative GPA of 3.0 or higher
  • F1 Students only - need to complete 3 consecutive full-time terms

Regulatory Affairs Topics

Additional elective options to meet the total required number of program quarter hours. 

4.00
4.00
2.00
2.00
2.00
 

Concentrations

Biopharmaceutical Regulatory Affairs

Complete the core courses below to meet the total number of program quarter hours:

2.00
4.00
4.00

Clinical Research Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours: 

4.00
4.00

Choose one of the following:

4.00
4.00

Medical Device Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:

2.00
4.00

Nonclinical Biomedical Product Regulation

Complete the core courses below to meet the total required number of program quarter hours: 

4.00
4.00

Quality Assurance and Compliance

Complete the core courses below to meet the total number of program quarter hours:

Choose one: 

2.00
2.00

4.00
3.00

Students in the Quality Assurance and Compliance concentration may enroll in RFA 6100, RGA 6000, or RGA 6001 to satisfy the core course requirement.

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)
  • 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.

Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.

Financing Requirements

International Students Tuition rate for International (Non-Canadian Resident): $38,657 CAD

How to Apply Learn more about the application process and requirements.

Cost and Tuition

Application Deadlines

 

 

Winter 2021 Deadline
November 2, 2020International out-of-country application complete (start date: January 19, 2021)
January 1, 2021Domestic application complete (first half start: January 19, 2021)
February 12, 2021Domestic application complete (second half start: February 22, 2021)
Fall 2021 Deadline
July 19, 2021International out-of-country application complete (start date: September 20, 2021)
August 23, 2021International in-country application complete (start date: September 20, 2021)
September 7, 2021Domestic application complete (first half start: September 20, 2021)
October 18, 2021Domestic application complete (second half start: November 1, 2021)

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.

 

  • Where They Work

    • Shire
    • Pfizer
    • Medtronic
    • Biogen
    • Teva Pharmaceuticals
  • What They Do

    • Legal
    • Research
    • Quality Assurance
    • Operations
    • Healthcare Services
  • 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.

Career Opportunities and Services

Overview

Did You Know?

About 137,000 new regulatory affairs jobs were filled in 2018.

Did You Know?

68% of regulatory professionals pursue graduate studies.

Did You Know?

By enrolling in Northeastern, you gain access to our global network of more than 255,000 alumni and 3,350+ employer partners. 

From Our Faculty

"Experienced regulatory professionals are in demand. A graduate degree in regulatory affairs will help advance your career." — Professor Stephen Amato

Did You Know?

Advanced degree holders earn a salary 35% higher than those with a bachelor's degree.