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Regulatory Affairs: Drugs, Biologics, and Medical Devices
College of Professional Studies

Regulatory Affairs: 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 Winter: Jan 5, 2015
Spring: April 6, 2015
Summer: July 6, 2015
Credits Required for Graduation 45 Quarter Hours
Tuition 2014-2015 Tuition
CurriculumView Curriculum
ApplicationApply | View Admissions Requirements
Download Program Overview Master of Science in Regulatory Affairs (PDF)
Visit the College of Professional Studies webpage

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As U.S. Food and Drug Administration laws and international policy perspectives change and evolve, the need for regulatory affairs professionals continues to grow.  The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices is designed to prepare regulatory affairs professionals with the knowledge surrounding the regulation of drug, biologic, and medical device commercialization in the global marketplace.

Courses cover compliance with applicable laws and regulations in the strategic analysis, communication, and commercialization of health care products. Program objectives focus on developing intellectual and practical frameworks to prepare you for work within regulatory affairs and quality assurance departments, medical product development, drug manufacturing, pharmaceutical sales, strategic marketing, and clinical investigations.

Offered fully online and in hybrid format, the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices allows you to focus on safety, surveillance, business, law, development, strategy, and international procedures surrounding the regulations in the health care industry.

Certificate Information:


If now is not the right time for you to enroll in a Northeastern University–Seattle 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!

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

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

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

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.