Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in Regulatory Compliance, 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 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6203Food, Drug, and Medical Device Law: Topics and Cases5
RGA 6207FDA and the Electronic Common Technical Document (eCTD)4
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Required Electives

Students must earn a minimum of 20 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations

Complete at least one of the following:4
Introduction to Safety Sciences
RGA 6208
Clinical Trial Design Optimization and Problem Solving
Validation and Auditing of Clinical Trial Information
Clinical Laboratory Management in Clinical Trials
Drug and Device Supplier Risk Management: Compliance and Processes
Advanced Writing on International Biomedical Topics

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:2-4
The Business of Medicine and Biotechnology
Biomedical Product Development: From Biotech to Boardroom to Market
Emerging Product Categories in the Regulation of Drugs and Biologics
Strategic Planning and Project Management for Regulatory Affairs
Regulation of Generic Pharmaceutical and Biosimilar Products
Emerging Trends and Issues in the Medical Device Industry
Combination Products and Convergence
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.)
Interdisciplinary Professional Foundations
Interdisciplinary Foundations
Integrative Experiential Learning
and Internship Reflection

International

Complete at least one of the following:4
European Union Compliance Process and Regulatory Affairs
European Medical Device Regulations
Introduction to Canadian, 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

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required