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

The Opportunity

As domestic and international laws and regulations change, the need for regulatory affairs professionals who can help companies navigate this ever-changing environment and bring biomedical products to market continues to grow. This escalating need makes regulatory affairs one of the most in-demand professions in the pharmaceutical, biotech, and medical device industries. And, of course, it is an attractive career option for those looking to make a real difference in the lives of people around the world.

The Program

Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices ALIGN Program is designed to build your knowledge of current regulations and their practical applications. Through your studies in clinical fields, law, policy, and business, you are prepared to work within a range of industry roles related to regulatory affairs, clinical affairs, and quality assurance.

As a student in this program, you have the opportunity to:

  • Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment
  • Learn the laws and regulations that govern the development, manufacturing, clinical testing, and commercialization of drugs, biologics, and medical devices in the U.S. and around the world
  • Analyze how emerging development and trends are reshaping biomedical device regulations
  • Prepare to take part in strategic planning, marketing, reimbursement activities, and even the development of regulatory policies
Annual salaries for managers in the pharmaceutical, biotech, and medical device industries average more than $100,000.

What Courses Will I Take? >>

The program’s comprehensive and evolving curriculum incorporates real-world case studies, individual and peer group-based project work, and classroom presentations. Content spans the complete medical products lifecycle. Elective courses cover safety and surveillance, business and law, development and strategy, and international procedures surrounding the regulations in the life science industry.

Core Courses Include:

  • Introduction to Drug and Medical Device Regulation
  • Human Experimentation: Methodological Issues Fundamental to Clinical Trials
  • New Drug Development: A Regulatory Overview
  • Biologics Development: A Regulatory Overview
  • Food, Drug, and Medical Device Law
  • Medical Device Development: A Regulatory Overview

Sample Electives Include:

  • Clinical Trial Design Optimization and Problem Solving
  • Global Awareness: Emerging Medical Device Markets
  • Understanding the Healthcare Landscape
  • Regulatory Writing: New Drug Applications
  • Managing International Clinical Trials
  • Combination Products: A Regulatory Overview
  • Regulation of Generic Pharmaceutical and Biosimilar Products
  • Global Biotechnology Product Registration

How Will I Gain Work Experience? >>

Northeastern’s respected co-op program enables you to gain invaluable work experience, apply classroom concepts, and earn credit toward your degree as you build the foundation of your regulatory affairs resumé.

Recent co-op partners include:

  • Takeda Pharmaceutical Company
  • Cubist Pharmaceuticals
  • Medtronic
  • Stryker Corporation

Who Are the Faculty Members? >>

Program Director: Irina Kulinets, Ph.D.

Our Faculty Members:

  • Are experienced, talented, and committed
  • Are professionals, scholars, and mentors
  • Provide valuable real-world experience

Am I Right for This Program? >>

Our Regulatory Affairs ALIGN Program is designed for students with a background in STEM and health-related disciplines who are interested in entering the growing field of regulatory affairs in biotech, pharmaceutical, and medical device industry sectors.

What Are the Admissions Requirements? >>

  • Completed application form and transcripts
  • Statement of purpose
  • Undergraduate degree in any discipline
  • Undergraduate GPA of 3.0 or higher
  • Two letters of recommendation
  • Resumé

How Much Will It Cost? >>

ALIGN is a customized degree program that includes bridge courses embedded into a full academic curriculum, as well as additional support and services related to your transition into Regulatory Affairs.

Tuition and fees are set on an annual basis by Northeastern University’s Board of Trustees. Based on rates for the 2013-2014 academic year, the total estimated cost for the MS Regulatory Affairs for Drugs, Biologics, and Medical Devices ALIGN program is $30,245.00.

Financial aid is available. Connect with your enrollment coach or contact us at for additional details.