Regulatory Affairs, MS

The rapid advancement of technology within healthcare and other sectors has driven the evolution of a complex global regulatory landscape and concurrently created the need for professionals with the skills necessary to facilitate the commercialization of products used therein. In response to this demand, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs degree.

This unique graduate degree is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and postmarketing of products utilized within regulated industries. Courses within this degree program provide students with the opportunity to integrate scientific and technical knowledge and engineering and regulatory perspectives within the larger context of global product commercialization. From research and discovery through the postmarket phase of product utilization, the Master of Science in Regulatory Affairs degree examines the processes required for stakeholders to maintain compliance to product standards and regulations throughout the global marketplace.

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

RGA 6002Introduction to Regulatory Compliance and Practice2
RGA 6203Pharmaceutical and Medical Device Law: Topics and Cases5
or RGA 6204 Legal Issues in International Food, Drug, and Medical Device Regulation
RGA 6212Introduction to Safety Sciences4
RGA 6463Regulatory Strategy for Product Development and Life-Cycle Management4

Capstone

RGA 6300Practical Applications in Global Regulatory Affairs4

Concentrations

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required

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.

Complete a minimum of one course from each category.6-12
Regulatory Operations
Introduction to Safety Sciences
Clinical Laboratory Management in Clinical Trials
Application of Quality System Regulation in Medical Device Design and Manufacturing
Regulatory Documentation Processes
Advanced Regulatory Writing: New Drug Applications
Food Safety and Surveillance: Concepts and Applications
Key Submissions for Food Regulatory Affairs
Regulatory Perspective: Product Development, Business, and Strategy
The Business of Medicine and Biotechnology
Personal and Career Development (Enrollment in COP 6940 requires participation in the cooperative education program, subject to availability.) 1
Interdisciplinary Foundations
Integrative Experiential Learning
and Internship Reflection
Strategic Planning and Project Management for Regulatory Affairs
Combination Products and Convergence
The Medical, Social, and Financial Dimensions of Orphan Drugs
Biomedical Product Development: From Biotech to Boardroom to Market
Emerging Product Categories in the Regulation of Drugs and Biologics
Regulation of Generic Pharmaceutical and Biosimilar Products
Financing and Reimbursement in Biomedical Product Development
Clinical Trial Quality Oversight
Real-World Evidence in Biomedical Research
International Regulatory Affairs
European Union Compliance Process and Regulatory Affairs
European Medical Device Regulations
Introduction to Australian, Asian, and Latin American Regulatory Affairs
Regulation of Biomedical Product Commercialization by Health Canada
Japanese Medical Device Regulations and Registration
Canadian and Australian Medical Device Regulations
Emerging Medical Device Markets
Working in Multicultural Environments: Challenges and Opportunities
Medicines Regulatory Harmonization in Africa
Global Economics of Food and Agriculture
Sustainable Development
Global Corporate and Social Responsibility

Regulatory Affairs Topics

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

RGA 6410Fundamentals of CMC Regulations and Methods4
RGA 6420Global IVD Regulations and Submissions4
RGA 6460Intellectual Property in the Life Sciences2
RGA 6461Cybersecurity and Regulation of Digital Health Technologies by the FDA2
RGA 6470Research Ethics2

Concentrations

Complete one of the following concentrations:

Biopharmaceutical Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4

Clinical Research Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
BTC 6211Validation and Auditing of Clinical Trial Information4
BTC 6213Clinical Trial Design Optimization and Problem Solving4
RGA 6100Introduction to Drug and Medical Device Regulation4
RGA 6101Therapeutic Product Development: A Regulatory Overview4
or RGA 6202 Medical Device Development: A Regulatory Overview

General Regulatory Affairs

BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4

International Regulatory Affairs

BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6204Legal Issues in International Food, Drug, and Medical Device Regulation5
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4

Medical Device Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6202Medical Device Development: A Regulatory Overview4

Nonclinical Biomedical Product Regulation

Complete the core courses below to meet the total required number of program quarter hours:
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6405Nonclinical Regulations in Biomedical Product Commercialization4

Operational Regulatory Affairs

RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6385Operational Aspects of Electronic Common Technical Document (eCTD) Submissions4

Quality Assurance and Compliance

Complete the core courses below to meet the total required number of program quarter hours:
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation 22
or RGA 6001 Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RGA 6234Risk Management: Compliance and Processes4
RFA 6100Introduction to Regulatory Affairs of Food and Food Industries 23

Strategic Regulatory Affairs

RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6210Strategic Planning and Project Management for Regulatory Affairs4
RGA 6217Biomedical Product Development: From Biotech to Boardroom to Market4