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Academic Catalog 2022-2023

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  • Regulatory Affairs, MS

Regulatory Affairs, MS

2022-2023 Edition

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  • Course Descriptions
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  • Overview
  • Program Requirements

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

Course List
Code Title Hours
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
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

Course List
Code Title Hours
RGA 6300Practical Applications in Global Regulatory Affairs4

The remaining quarter hours may be completed by selecting a combination of a concentration and additional electives or selecting any courses listed in the concentrations and elective lists. 

Concentrations

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

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required

Elective Courses

Course List
Code Title Hours
General Electives
COP 6940
Personal and Career Development
EDU 6184
Interdisciplinary Foundations
INT 6943
Integrative Experiential Learning
RGA 6205
Emerging Trends and Issues in the Medical Device Industry
RGA 6210
Strategic Planning and Project Management for Regulatory Affairs
RGA 6215
Project Management in Early Drug Discovery and Development
RGA 6217
Biomedical Product Development: From Biotech to Boardroom to Market
RGA 6219
Advanced Topics in Advertising and Promotion of Drugs and Medical Devices
RGA 6255
Global Convergence of Regulatory Science and Reimbursement/Market Access
RGA 6461
Cybersecurity and Regulation of Digital Health Technologies by the FDA
Regulatory Affairs of Food
GST 6350
Global Economics of Food and Agriculture
GST 6610
Sustainable Development
GST 6102
Global Corporate Social Responsibility
RFA 6220
Food Safety and Surveillance: Concepts and Applications
International Regulatory Affairs
RGA 6221
European Union Compliance Process and Regulatory Affairs
RGA 6222
European Medical Device Regulations
RGA 6223
Introduction to Australian, Asian, and Latin American Regulatory Affairs
RGA 6224
Regulation of Biomedical Product Commercialization by Health Canada
RGA 6228
Managing International Clinical Trials
RGA 6228
Managing International Clinical Trials
RGA 6243
Medical Device Product Development in Canada
RGA 6244
Therapeutic Product Development in Canada
RGA 6247
Medicines Regulatory Harmonization in Africa
RGA 6249
Chinese Food and Drug Administration Regulation of Biomedical Product Commercialization

Concentrations

Biopharmaceutical Regulatory Affairs

Course List
Code Title Hours
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
RGA 6380Advanced Regulatory Writing: New Drug Applications4
Complete one of the following:4
RGA 6217
Biomedical Product Development: From Biotech to Boardroom to Market
RGA 6235
Emerging Product Categories in the Regulation of Drugs and Biologics

Clinical Research Regulatory Affairs

Course List
Code Title Hours
BTC 6211Validation and Auditing of Clinical Trial Information4
BTC 6213Clinical Trial Design Optimization and Problem Solving4
RGA 6101Therapeutic Product Development: A Regulatory Overview4
or RGA 6202 Medical Device Development: A Regulatory Overview
Complete one of the following:4
RGA 6217
Biomedical Product Development: From Biotech to Boardroom to Market
RGA 6228
Managing International Clinical Trials

Medical Device Regulatory Affairs

Course List
Code Title Hours
RGA 6001Introduction to Food and Drug Administration (FDA) Medical Device Regulation2
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
Choose from the following:6
RGA 6205
Emerging Trends and Issues in the Medical Device Industry
RGA 6222
European Medical Device Regulations
RGA 6243
Medical Device Product Development in Canada
RGA 6275
Product Development and Process Validation
RGA 6370
Advanced Regulatory Writing: Medical Device Submissions

Nonclinical Biomedical Product Regulation

Course List
Code Title Hours
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6405Nonclinical Regulations in Biomedical Product Commercialization4
RGA 6420Global IVD Regulations and Submissions4

Quality Assurance and Compliance

Course List
Code Title Hours
Complete one of the following:2-3
RGA 6000
Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6001
Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RFA 6100
Introduction to Regulatory Affairs of Food and Food Industries
Complete the following:
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6234Risk Management: Compliance and Processes4
RGA 6275Product Development and Process Validation2
Choose from the following to reach 16 quarter hours:3-4
RGA 6221
European Union Compliance Process and Regulatory Affairs
RGA 6410
Fundamentals of CMC Regulations and Methods
RFA 6220
Food Safety and Surveillance: Concepts and Applications
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