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.
|RGA 6002||Regulatory Compliance Culture||2|
|RGA 6203||Pharmaceutical and Medical Device Law: Topics and Cases||5|
|or RGA 6204||Legal Issues in International Food, Drug, and Medical Device Regulation|
|RGA 6207||Global Impact of Electronic Common Technical Document (eCTD) Submissions||4|
|RGA 6215||Project Management in Early Drug Discovery and Development||4|
|RGA 6300||Practical Applications in Biomedical Product Global Regulatory Affairs||4|
|RGA 6405||Nonclinical Regulations in Biomedical Product Commercialization||4|
|RGA 6410||Fundamentals of CMC Regulations and Methods||4|
Students must earn a minimum of 18 quarter hours by choosing course work from the electives listed below.
|RGA 6101||Therapeutic Product Development: A Regulatory Overview||4|
|RGA 6112||Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets||4|
|RGA 6202||Medical Device Development: A Regulatory Overview||4|
|RGA 6210||Strategic Planning and Project Management for Regulatory Affairs||4|
|RGA 6233||Application of Quality System Regulation in Medical Device Design and Manufacturing||4|
|RGA 6234||Drug and Device Supplier Risk Management: Compliance and Processes||4|
|RGA 6245||Regulation of Generic Pharmaceutical and Biosimilar Products||4|
|RGA 6250||Financing and Reimbursement in Biomedical Product Development||4|
|RGA 6310||Regulatory Documentation Processes||4|
|RGA 6370||Advanced Regulatory Writing: Medical Device Submissions||4|
|RGA 6380||Advanced Regulatory Writing: New Drug Applications||4|
|RGA 6420||Global IVD Regulations and Submissions||4|
|RGA 6460||Intellectual Property in the Life Sciences||2|
|RGA 6463||Regulatory Strategy for Product Development and Life-Cycle Management||4|
|RGA 6461||Cybersecurity and Regulation of Digital Health Technologies by the FDA||2|
Program Credit/GPA Requirements
45 total quarter hours required
Minimum 3.000 GPA required