Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in Quality Assurance and 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

BTC 6210Human Experimentation: Methodological Issues Fundamentals4
BTC 6211Validation and Auditing of Clinical Trial Information4
RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2
RGA 6002Regulatory Compliance Culture2
RGA 6203Pharmaceutical and Medical Device Law: Topics and Cases5
RGA 6234Drug and Device Supplier Risk Management: Compliance and Processes4
RGA 6275Product Development and Process Validation2
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4

Required Electives

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

Regulatory and Clinical Operations

Complete at least one of the following:4
Clinical Trial Design Optimization and Problem Solving
Introduction to Safety Sciences
Clinical Laboratory Management in Clinical Trials
Application of Quality System Regulation in Medical Device Design and Manufacturing
Regulatory Compliance in the Pharmaceutical Industry: A Collaborative Approach
Global Impact of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:2-4
Emerging Trends and Issues in the Medical Device Industry
Strategic Planning and Project Management for Regulatory Affairs
Combination Products and Convergence
Emerging Product Categories in the Regulation of Drugs and Biologics
Regulation of Generic Pharmaceutical and Biosimilar Products
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
Legal Issues in International Food, Drug, and Medical Device Regulation
European Union Compliance Process and Regulatory Affairs
European Medical Device Regulations
Introduction to Australian, 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
Managing International Clinical Trials
Medicines Regulatory Harmonization in Africa

Special Topics

Complete at least one of the following:
Fundamentals of CMC Regulations and Methods
Global IVD Regulations and Submissions
Clinical Trial Quality Oversight
Clinical Trial Agreements and Other Key Contracts in the Life Sciences
Cybersecurity and Regulation of Digital Health Technologies by the FDA

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required