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

BTC 6210Human Experimentation: Methodological Issues Fundamentals4
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 6204Legal Issues in International Food, Drug, and Medical Device Regulation4
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6223Introduction to Canadian, Asian, and Latin American Regulatory Affairs4
RGA 6241Working in Multicultural Environments: Challenges and Opportunities2
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Required Electives

Students must earn a minimum of 15 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations

Complete at least one of the following:3-4
Validation and Auditing of Clinical Trial Information
Clinical Trial Design Optimization and Problem Solving
Introduction to Safety Sciences
Advanced Regulatory Writing: Medical Device Submissions
Advanced Regulatory Writing: New Drug Applications
Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective

Complete at least one of the following:2-5
Pharmaceutical 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
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
Interdisciplinary Foundations

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
Emerging Medical Device Markets
Managing International Clinical Trials
Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan
Combination Products and Convergence
Therapeutic Product Development in Canada
Medical Device Product Development in Canada
RGA 6240
Chinese Food and Drug Administration Regulation of Biomedical Product Commercialization
Medicines Regulatory Harmonization in Africa

 Special Topics

Complete at least one of the following:
Fundamentals of CMC Regulations and Methods
Preparing EU Medical Device Clinical Evaluations
Intellectual Property in the Life Sciences
Global IVD Regulations and Submissions
RGA 6246
Regulatory Compliance Culture

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required