Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in Operational 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 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 6203Pharmaceutical and Medical Device Law: Topics and Cases5
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6385Operational Aspects of Electronic Common Technical Document (eCTD) Submissions4
RGA 6248Global Regulatory Operations2
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Required Electives

Students must earn a minimum of 14 quarter hours by completing at least three courses from the lists below.

Regulatory and Clinical Operations

Human Experimentation: Methodological Issues Fundamentals
Validation and Auditing of Clinical Trial Information
Introduction to Safety Sciences
Regulatory Documentation Processes
Advanced Regulatory Writing: Medical Device Submissions
Advanced Regulatory Writing: New Drug Applications

Regulatory Perspective: Product Development, Business, and Strategy

The Business of Medicine and Biotechnology
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
Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
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

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
Working in Multicultural Environments: Challenges and Opportunities
Medicines Regulatory Harmonization in Africa
Legal Issues in International Food, Drug, and Medical Device Regulation

Special Topics

Cybersecurity and Regulation of Digital Health Technologies by the FDA
Clinical Trial Agreements and Other Key Contracts in the Life Sciences
Intellectual Property in the Life Sciences
Global IVD Regulations and Submissions
Fundamentals of CMC Regulations and Methods

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required