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

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

Program Name Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
College Name College of Professional Studies
Entry Terms Fall Quarter, Winter Quarter,
Spring Quarter, Summer Quarter
Credits Required for Graduation 45 Quarter Hours
Tuition 2014-2015 Tuition
ApplicationApply | Graduate Admissions
CurriculumView Curriculum
Download Program OverviewMaster of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices (PDF)

View a PowerPoint presentation by Eric Kupferberg, PhD, senior fellow and faculty member in Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, on “Leading in the Field of Regulatory Affairs.”

View a recorded webinar on,“Regulatory Developments: The Future of Medical and Food Technology”.

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. 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.

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

Certificate Information:

If now is not the right time for you to enroll in a Northeastern University–Charlotte master’s degree program, but you know that advanced study will enhance your skills and career potential, consider our graduate certificate programs.

Keep pace with the latest advances in your field. Develop new skills and insights. Discover how Northeastern University’s global network of active, committed professionals keeps you Networked for Advancement. Plus, apply your certificate credits to the related Northeastern master’s degree program when the time is right!

Medical Devices Regulatory Affairs

The Graduate Certificate in Medical Devices Regulatory Affairs provides an in-depth knowledge of the regulations and standards that apply to the development of medical devices, including those products not specifically regulated by federal law. The program will review the global applications of the medical device industry. Students will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S., as well as the social and financial impact of the medical devices industry on the aging population.  Learn More

Biopharmaceutical International Regulatory Affairs

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the company. As a result of the program, students will gain an understanding of international regulatory requirements for countries where new products will be marketed. Learn More

Biopharmaceutical Domestic Regulatory Affairs

The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of medical device regulation and the industry’s unique software development and validation issues. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Learn More

ALIGN Master’s Degree Program

Interested in our Regulatory Affairs Program but think your background might not be a match? Consider our ALIGN program. Created specifically to prepare bachelor’s degree holders for high-demand industries, regardless of their experience or undergraduate major, ALIGN offers custom curricula in hybrid formats on all our campuses and includes the benefits of our co-op experience and Northeastern’s global network. To learn more, visit our ALIGN website.

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