Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in General Regulatory Affairs, MS

The rapid growth of the biomedical product industries and the ever-evolving regulatory landscape have driven high demand for trained regulatory affairs professionals in both the public and private sectors. In response to this demand, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

This unique graduate degree is designed to both broaden and deepen the student’s understanding of current regulations and their practical application in the development of biomedical products. Courses within this program provide students with the opportunity to integrate both scientific knowledge and regulatory perspectives, within the larger context of global commercialization. From discovery through the postmarket phase of product development, this master’s degree covers the regulatory and market access requirements to bring a medical product to—and maintain its presence in—the global marketplace.

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

RGA 6100Introduction to Drug and Medical Device Regulation4
BTC 6210Human Experimentation: Methodological Issues Fundamentals4
RGA 6201New Drug Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6200Biologics Development: A Regulatory Overview4
RGA 6203Food, Drug, and Medical Device Law: Topics and Cases5
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Required Electives

Students must earn a minimum of 16 quarter hours by choosing at least one course from each category.

Regulatory and Clinical Operations

Complete at least one of the following:4
Validation and Auditing of Clinical Trial Information
Clinical Trial Design Optimization and Problem Solving
Introduction to Safety Sciences
Clinical Laboratory Management in Clinical Trials
Advanced Writing on International Biomedical Topics
Regulatory Documentation Processes
Regulatory Writing: Medical Device Submissions
Regulatory Writing: New Drug Applications
Application of Quality System Regulation in Medical Device Design and Manufacturing
Drug and Device Supplier Risk Management: Compliance and Processes

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:4
The Business of Medicine and Biotechnology
The Medical, Social, and Financial Dimensions of Orphan Drugs
Biomedical Product Development: From Biotech to Boardroom to Market
The Advertising and Promotion of Drug and Medical Device Products
Clinical Drug Development Data Analysis: Concepts
Biomedical Intellectual Property Management: Patents
Emerging Trends and Issues in the Medical Device Industry
Strategic Planning and Project Management for Regulatory Affairs
Combination Products and Convergence
Regulation of Generic Pharmaceutical and Biosimilar Products
Financing and Reimbursement in Biomedical Product Development
Personal and Career Development (Enrollment in COP 6940 requires participation in the cooperative education program [subject to availability.] Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210.)
Integrative Experiential Learning
and Internship Reflection

International

Complete at least one of the following:4-5
Global Biotechnology Product Registration: E.U., U.S. Product Regulation
European Union Compliance Process and Regulatory Affairs
European Medical Device Regulations
Introduction to Canadian, Asian, and Latin American Regulatory Affairs
RGA 6224Regulation of Biomedical Product Commercialization by Health Canada4
Japanese Medical Device Regulations and Registration
Canadian and Australian Medical Device Regulations
Emerging Medical Device Markets
Managing International Clinical Trials

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required