Regulatory Affairs for Drugs, Biologics, and Medical Devices

Program Format
Application Deadlines
Spring Term 2018
- March 30th
- May 11th

Summer Term 2018
- June 29th

Fall Term 2018
- September 7th
- October 19th

Winter Term 2019
- December 21st
- February 8th
Credits Required for Graduation
45 Quarter Hours

Program Description

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 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.

Offered fully online and in a hybrid format, the MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices allows students to choose one of six unique concentrations offerings: Operational Regulatory Affairs, Strategic Regulatory Affairs, Clinical Research Regulatory Affairs, International Regulatory Affairs, Regulatory Compliance, or General Regulatory Affairs.


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.)

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 regulation 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.

Find Out More

Generally speaking, the pharmaceutical and medicine manufacturing industry is not highly sensitive to changes in economic conditions—consistently experiencing growth in both jobs and profits. Because they are relied upon to get new drugs and devices tested, approved, and put on the market, regulatory affairs specialists are continually in demand. While employment prospects are bright across the field, regulatory affairs professionals with the most education are likely to enjoy the most opportunities and highest pay.

Watch our Regulatory Affairs Webinar.

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