Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in International 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
RGA 6201New Drug Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6200Biologics Development: A Regulatory Overview4
RGA 6220Global Biotechnology Product Registration: E.U., U.S. Product Regulation5
RGA 6223Introduction to Canadian, Asian, and Latin American Regulatory Affairs4
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 elective category.

Regulatory and Clinical Operations

Complete at least one of the following:4
Validation and Auditing of Clinical Trial Information
Introduction to Safety Sciences
Clinical Trial Design Optimization and Problem Solving
RGA 6370Regulatory Writing: Medical Device Submissions4
RGA 6380Regulatory Writing: New Drug Applications4
Advanced Writing on International Biomedical Topics

Regulatory Perspective

Complete at least one of the following:4-5
Food, Drug, and Medical Device Law: Topics and Cases
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
Emerging Trends and Issues in the Medical Device Industry
Strategic Planning and Project Management for Regulatory Affairs
Regulation of Generic Pharmaceutical and Biosimilar Products
Combination Products and Convergence
COP 6940Personal 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.)4
INT 6943
and RGA 6920
Integrative Experiential Learning
and Internship Reflection
4

International

Complete at least one of the following:4
European Union Compliance Process and Regulatory Affairs
European Medical Device Regulations
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
RGA 6229Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan4
Combination Products and Convergence

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required