Regulatory Affairs

Degree:
  • Master's
Location: Boston
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Why Regulatory Affairs ?

The Master of Science in Regulatory Affairs program is designed to produce graduates who are highly qualified to manage global regulatory process for companies innovating and developing cutting-edge products in healthcare and food safety.

The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring highly regulated 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. This unique graduate degree is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.

Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a highly regulated product to market, both in the U.S. and around the globe.

Northeastern’s MS in Regulatory Affairs offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:

  • Biopharmaceutical Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • Medical Device Regulatory Affairs 
  • Nonclinical Biomedical Product Regulation
  • Quality Assurance and Compliance 

More Details

Unique Features

  • Boston location is a hub for healthcare, education, finance, business, biotechnology, and the life sciences.
  • Students can focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
  • Students will participate in integrative experiential learning and/or the cooperative education program as part of their course of study.
  • Students will have the opportunity to forge connections with our global network of alumni from some of the world's most renowned companies, including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestle, Pepsico, and Coca-Cola.
  • As a Northeastern University student and alumnus, you'll have access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.
  • This program has a science, technology, engineering, and mathematics (STEM) designation. This means international students with an F-1 visa can apply for a 24-month OPT STEM Extension to their 12-month Optional Practical Training (OPT) period, which allows them to work in the U.S. for up to 36 months after graduation. Non-US students may take a certain number of online courses as approved by their advisor as long as they are enrolled in the required amount of on-ground coursework at our Boston or Silicon Valley campuses per term.In these approved instances, the degree is STEM eligible.

Program Objectives

Successful completion of the MS-RA Program will enable students to:

  • Gain the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment.
  • Acquire the professional foundations necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, clinical research, and food safety.
  • Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
  • Refine your understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of drugs, biologics, medical devices, and food safety.
  • Analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations.

Concentrations

  • Biopharmaceutical Regulatory Affairs—Learn how to apply statuses to the submission of marketing approval applications for both pharmaceutical and biological products to global regulatory agencies.
  • Clinical Research Regulatory Affairs—Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support biomedical product development.
  • Medical Device Regulatory Affairs—Learn how to apply statutes of the submission of marketing approval applications for medical device products to global regulatory agencies.
  • Nonclinical Biomedical Product Regulation—Study the regulations applicable to biomedical product commercialization from pre-clinical development, quality, and manufacturing perspectives.
  • Quality Assurance and Compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products.

What you'll study

General Requirements

Master of Science in Regulatory Affairs General Requirements
RGA 6002 - Introduction to Regulatory Compliance and Practice
2.00
RGA 6203 - Pharmaceutical and Medical Device Law: Topics and Cases
5.00
RGA 6204 - Legal Issues in International Food, Drug, and Medical Device Regulation
5.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6463 - Regulatory Strategy for Product Development and Life-Cycle Management
4.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00

Note:  Students may select RGA 6203 or RGA 6204.

Capstone

RGA 6300 - Practical Applications in Global Regulatory Affairs
4.00
 

Required Electives

Complete electives to meet the total required number of program quarter hours. One course must be chosen from each category below, and additional electives may come from those lists or the topics list.

Regulatory Operations

RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6230 - Clinical Laboratory Management in Clinical Trials
4.00
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6310 - Regulatory Documentation Processes
4.00
RGA 6380 - Advanced Regulatory Writing: New Drug Applications
4.00
RFA 6220 - Food Safety and Surveillance: Concepts and Applications
3.00
RFA 6205 - Key Submissions for Food Regulatory Affairs
3.00

Regulatory Perspective: Product Development, Business, and Strategy

BTC 6260 - The Business of Medicine and Biotechnology
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
EDU 6184 - Interdisciplinary Foundations
2.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6211 - Combination Products and Convergence
4.00
RGA 6216 - The Medical, Social, and Financial Dimensions of Orphan Drugs
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6250 - Financing and Reimbursement in Biomedical Product Development
4.00
RGA 6430 - Clinical Trial Quality Oversight
2.00
RGA 6432 - Real-World Evidence in Biomedical Research
2.00

International Regulatory Affairs

RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6223 - Introduction to Australian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00
RGA 6241 - Working in Multicultural Environments: Challenges and Opportunities
2.00
RGA 6247 - Medicines Regulatory Harmonization in Africa
2.00
GST 6350 - Global Economics of Food and Agriculture
4.00
GST 6610 - Sustainable Development
4.00
GST 6102 - Global Corporate and Social Responsibility
4.00

Please Note: Prior to enrolling in COP 6940 Personal and Career Development (COP 6940), students must:

  • complete 20 credit hours in the current program of study
  • maintain a cumulative GPA of 3.0 or higher
  • F1 Students only - need to complete 3 consecutive full-time terms

Regulatory Affairs Topics

Additional elective options to meet the total required number of program quarter hours. 

RGA 6410 - Fundamentals of CMC Regulations and Methods
4.00
RGA 6420 - Global IVD Regulations and Submissions
4.00
RGA 6460 - Intellectual Property in the Life Sciences
2.00
RGA 6461 - Cybersecurity and Regulation of Digital Health Technologies by the FDA
2.00
RGA 6470 - Research Ethics
2.00
 

Concentrations

Biopharmaceutical Regulatory Affairs

Complete the core courses below to meet the total number of program quarter hours:

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6207 - Global Impact of Electronic Common Technical Document (eCTD) Submissions
4.00
Clinical Research Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours: 

BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00

Choose one of the following:

RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
Medical Device Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:

RGA 6001 - Introduction to Food and Drug Administration (FDA) Medical Device Regulation
2.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
Nonclinical Biomedical Product Regulation

Complete the core courses below to meet the total required number of program quarter hours: 

RGA 6207 - Global Impact of Electronic Common Technical Document (eCTD) Submissions
4.00
RGA 6405 - Nonclinical Regulations in Biomedical Product Commercialization
4.00
Quality Assurance and Compliance

Complete the core courses below to meet the total number of program quarter hours:

Choose one: 

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6001 - Introduction to Food and Drug Administration (FDA) Medical Device Regulation
2.00
RGA 6234 - Risk Management: Compliance and Processes
4.00
RFA 6100 - Introduction to Regulatory Affairs of Food and Food Industries
3.00

Students in the Quality Assurance and Compliance concentration may enroll in RFA 6100, RGA 6000, or RGA 6001 to satisfy the core course requirement.

This program requires successful completion of a minimum of 45 credit hours that meet the degree requirements.

Thinking about earning your graduate degree?

Join the Virtual Graduate Open House on Oct. 17.

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Did You Know?

About 137,000 new regulatory affairs jobs were filled in 2018.

Average Time to Completion

1.5 - 2 years

Commitment

Full-Time
Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Meets F-1 Visa Requirements

Yes