The rapid advancement of technology within healthcare and other sectors has driven the evolution of a complex global regulatory landscape and concurrently created the need for professionals with the skills necessary to facilitate the commercialization of products used therein. In response to this demand, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs degree.
This unique graduate degree is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and post-marketing of products utilized within regulated industries. Courses within this degree program offer students an opportunity to integrate scientific and technical knowledge and engineering and regulatory perspectives within the larger context of global product commercialization. From research and discovery through the post-market phase of product utilization, the Master of Science in Regulatory Affairs degree examines the processes required for stakeholders to maintain compliance to product standards and regulations throughout the global marketplace.
Required Courses
Course List | Code | Title | Hours |
| BTC 6210 | Human Experimentation: Methodological Issues Fundamentals | 4 |
| RGA 6002 | Introduction to Regulatory Compliance and Practice | 2 |
| RGA 6300 | Practical Applications in Global Regulatory Affairs | 4 |
| RGA 6212 | Introduction to Safety Sciences | 4 |
| RGA 6463 | Regulatory Strategy for Product Development and Life-Cycle Management | 4 |
| 5 |
| Pharmaceutical and Medical Device Law: Topics and Cases | |
| Legal Issues in International Food, Drug, and Medical Device Regulation | |
Concentrations
A concentration is not required. The remaining required quarter hours for this program may be completed by selecting a combination of a concentration and electives or selecting any courses listed in the concentrations and electives.
Program Credit/GPA Requirements
45 total quarter hours required
Minimum 3.000 GPA required
Concentration in Biopharmaceutical Regulatory Affairs
Course List | Code | Title | Hours |
| RGA 6000 | Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | 2 |
| RGA 6101 | Therapeutic Product Development: A Regulatory Overview | 4 |
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| 4 |
| Biomedical Product Development: From Biotech to Boardroom to Market | |
| Emerging Product Categories in the Regulation of Drugs and Biologics | |
Concentration in Clinical Research Regulatory Affairs
Course List | Code | Title | Hours |
| BTC 6211 | Validation and Auditing of Clinical Trial Information | 4 |
| BTC 6213 | Clinical Trial Design Optimization and Problem Solving | 4 |
| 2 |
| Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | |
| Introduction to Food and Drug Administration (FDA) Medical Device Regulation | |
| 4 |
| Therapeutic Product Development: A Regulatory Overview | |
| Medical Device Development: A Regulatory Overview | |
| Managing International Clinical Trials | |
Concentration in Medical Device Regulatory Affairs
Course List | Code | Title | Hours |
| RGA 6001 | Introduction to Food and Drug Administration (FDA) Medical Device Regulation | 2 |
| RGA 6202 | Medical Device Development: A Regulatory Overview | 4 |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| 2-4 |
| Emerging Trends and Issues in the Medical Device Industry | |
| European Medical Device Regulations | |
| Medical Device Product Development in Canada | |
| Product Development and Process Validation | |
| Advanced Regulatory Writing: Medical Device Submissions | |
Concentration in Nonclinical Biomedical Product Regulation
Course List | Code | Title | Hours |
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| RGA 6405 | Nonclinical Regulations in Biomedical Product Commercialization | 4 |
| 2 |
| Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | |
| Introduction to Food and Drug Administration (FDA) Medical Device Regulation | |
Concentration in Quality Assurance and Compliance
Course List | Code | Title | Hours |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6234 | Risk Management: Compliance and Processes | 4 |
| 2 |
| Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | |
| Introduction to Food and Drug Administration (FDA) Medical Device Regulation | |
| Cybersecurity and Regulation of Digital Health Technologies by the FDA | |
| 4 |
| European Union Compliance Process and Regulatory Affairs | |
| Fundamentals of CMC Regulations and Methods | |
Electives
Course List | Code | Title | Hours |
| Experiential Project Preparation | |
| Advanced Topics in Advertising and Promotion of Drugs and Medical Devices | |
| Therapeutic Product Development in Canada | |
