Regulatory Affairs for Drugs, Biologics, and Medical Devices with Concentration in Non-Clinical Biomedical Product Regulation, 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 offer students an 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 6002Regulatory Compliance Culture2
RGA 6203Pharmaceutical and Medical Device Law: Topics and Cases5
or RGA 6204 Legal Issues in International Food, Drug, and Medical Device Regulation
RGA 6207Global Impact of Electronic Common Technical Document (eCTD) Submissions4
RGA 6215Project Management in Early Drug Discovery and Development4
RGA 6300Practical Applications in Biomedical Product Global Regulatory Affairs4
RGA 6405Nonclinical Regulations in Biomedical Product Commercialization4
RGA 6410Fundamentals of CMC Regulations and Methods4

Required Electives

Students must earn a minimum of 18 quarter hours by choosing course work from the electives listed below.

RGA 6101Therapeutic Product Development: A Regulatory Overview4
RGA 6112Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets4
RGA 6202Medical Device Development: A Regulatory Overview4
RGA 6210Strategic Planning and Project Management for Regulatory Affairs4
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6234Drug and Device Supplier Risk Management: Compliance and Processes4
RGA 6245Regulation of Generic Pharmaceutical and Biosimilar Products4
RGA 6250Financing and Reimbursement in Biomedical Product Development4
RGA 6310Regulatory Documentation Processes4
RGA 6370Advanced Regulatory Writing: Medical Device Submissions4
RGA 6380Advanced Regulatory Writing: New Drug Applications4
RGA 6420Global IVD Regulations and Submissions4
RGA 6460Intellectual Property in the Life Sciences2
RGA 6463Regulatory Strategy for Product Development and Life-Cycle Management4
RGA 6461Cybersecurity and Regulation of Digital Health Technologies by the FDA2

Program Credit/GPA Requirements

45 total quarter hours required
Minimum 3.000 GPA required