Regulatory Affairs
College of Professional Studies

Regulatory Affairs Overview

Program Name Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
College Name College of Professional Studies
Entry Terms Fall 2012: September 10, 2012
Winter 2013: January 7, 2013
Spring 2013: April 8, 2013
Summer 2013: July 1, 2013
Credits Required for Graduation 45 Quarter Hours
CurriculumView Curriculum
ApplicationApply | View Admissions Requirements
Download Program OverviewRegulatory Affairs (PDF)
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As the field of Regulatory Affairs continues to grow, professionals with a thorough understanding of the complexities of medical product regulation and the role of the FDA and international bodies are in greater demand. Northeastern University offers a unique graduate program that will address regulatory affairs within each category of regulated agents: drugs, biologics, and medical devices.

The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices is designed to educate and prepare RA professionals to play a pivotal role in ensuring compliance with applicable laws and regulations in the strategic development and commercialization of health care products. The regulatory affairs curriculum—continually evolving to stay on pace with industry changes—prepares you for work within RA and QA departments, medical product development, pharmaceutical sales, strategic marketing, and clinical investigations.

Program Objectives
  • Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment
  • Examine every step of the drug development and regulation process from R&D and clinical trials to manufacturing, marketing, distribution and post-market surveillance
  • Sharpen 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

* Tuition rates are for the 2012-2013 academic year beginning on July 1, 2012. Tuition and fees are subject to revision by the president and Board of Trustees at any time.