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

General

Program Description

This is Canada’s only master’s degree in regulatory affairs, focused on the development and commercialization
of drugs, biologics, and medical device products.

Key differentiators of our program:

  • Six unique concentrations: Operational Regulatory Affairs, Strategic Regulatory Affairs, Clinical Research Regulatory Affairs, International Regulatory Affairs, Regulatory Compliance, or General Regulatory Affairs.
  • Choose the learning format that meets your needs (100% online or flexible hybrid format that combines online and in-class instruction).
  • Experiential learning: Acquire hands-on experience through in-the-field research, capstone projects, co-op opportunities, or integrative learning experience at your current employer.

Admissions at the College of Professional Studies operates on a rolling basis, meaning that applications are reviewed as they are received, and there are multiple intakes over the course of the academic year. See below for upcoming academic terms along with the application deadline for each.

Why Regulatory Affairs?

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 the regulatory process for companies innovating and developing cutting-edge products in science and medicine.

Ever-changing laws and regulations are driving demand for regulatory affairs professionals who can help companies effectively bring medical products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the online Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices. This unique graduate degree is designed to deepen your understanding of current regulations and their practical application in the development and commercialization of drugs, biologics, and medical device products.

Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the regulatory process. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a medical product to market, both in the U.S. and around the globe. Delivered entirely online, graduate courses address critical regulatory issues affecting all of the stages and processes in regulatory affairs.

Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals in the fields of regulatory affairs — such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance — by focusing their education in one of eight unique concentrations that span the entire discipline. Concentration offerings include:

  • Clinical Research Regulatory Affairs
  • General Regulatory Affairs
  • International Regulatory Affairs
  • Operational Regulatory Affairs
  • Strategic Regulatory Affairs
  • Medical Device Regulatory Affairs
  • Quality Assurance and Compliance
  • Non-clinical Biomedical Product Regulation
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Energepic/ Pexels

Program Objectives

  • Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment.
  • Acquire the foundation necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, and clinical investigations.
  • Examine every step of the drug development and regulatory process.
  • Sharpen your understanding of the laws that govern the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices.
  • Analyze how emerging developments and trends are reshaping medical device regulations.

Admissions Requirements

1. Online application
2. Statement of purpose (500-1000 words)
3. Professional resumé
4. Unofficial undergraduate transcripts
5. Two letters of recommendation
6. English Language Proficiency Proof: Students for whom English is not their primary language must submit one of the following:

  • Official bachelor’s degree transcript from an accredited college or university in the U.S., stating degree conferral and date
  • TOEFL, IELTS, Pearson (PTE), or NU Global Exam scores

Please Note: This program is offered under the written consent of the Minister of Training, Colleges, and Universities for the period from October 28, 2015, to October 27, 2020. 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).

Last updated Mar 2020

About the School

Founded in 1898, Northeastern is a top 50 global research university and the recognized leader in experiential learning, anchored in the world’s largest and most innovative cooperative education progr ... Read More

Founded in 1898, Northeastern is a top 50 global research university and the recognized leader in experiential learning, anchored in the world’s largest and most innovative cooperative education program. We integrate classroom studies with opportunities for professional work, research, service, and global learning in 128 countries. Read less
Toronto , Vancouver + 1 More Less