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 postmarketing 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 postmarket 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.
- Concentrations and course offerings may vary by campus and/or by program modality. Please consult with your advisor or admissions coach for the course availability each term at your campus or within your program modality.
- Certain options within the program may be required at certain campuses or for certain program modalities. Please consult with your advisor or admissions coach for requirements at your campus or for your program modality.
Complete all courses and requirements listed below unless otherwise indicated.
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 6203 | Pharmaceutical and Medical Device Law: Topics and Cases | 5 |
| or RGA 6204 | Legal Issues in International Food, Drug, and Medical Device Regulation |
| RGA 6212 | Introduction to Safety Sciences | 4 |
| RGA 6463 | Regulatory Strategy for Product Development and Life-Cycle Management | 4 |
Capstone
Course List | Code | Title | Hours |
| RGA 6300 | Practical Applications in Global Regulatory Affairs | 4 |
The remaining quarter hours may be completed by selecting a combination of a concentration and additional electives or selecting any courses listed in the concentrations and electives lists.
Concentrations
Program Credit/GPA Requirements
45 total quarter hours required
Minimum 3.000 GPA required
Elective Courses
Course List | Code | Title | Hours |
| Personal and Career Development | |
| Interdisciplinary Foundations | |
| Integrative Experiential Learning | |
| Emerging Trends and Issues in the Medical Device Industry | |
| Strategic Planning and Project Management for Regulatory Affairs | |
| Project Management in Early Drug Discovery and Development | |
| Biomedical Product Development: From Biotech to Boardroom to Market | |
| Advanced Topics in Advertising and Promotion of Drugs and Medical Devices | |
| Global Convergence of Regulatory Science and Reimbursement/Market Access | |
| Cybersecurity and Regulation of Digital Health Technologies by the FDA | |
| Global Economics of Food and Agriculture | |
| Sustainable Development | |
| Global Corporate Social Responsibility | |
| Food Safety and Surveillance: Concepts and Applications | |
| 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 | |
| Managing International Clinical Trials | |
| Managing International Clinical Trials | |
| Medical Device Product Development in Canada | |
| Therapeutic Product Development in Canada | |
Concentrations
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 |
| RGA 6380 | Advanced Regulatory Writing: New Drug Applications | 4 |
| 4 |
| Biomedical Product Development: From Biotech to Boardroom to Market | |
| Emerging Product Categories in the Regulation of Drugs and Biologics | |
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 |
| RGA 6101 | Therapeutic Product Development: A Regulatory Overview | 4 |
| or RGA 6202 | Medical Device Development: A Regulatory Overview |
| 4 |
| Biomedical Product Development: From Biotech to Boardroom to Market | |
| Managing International Clinical Trials | |
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 |
| 6 |
| 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 | |
Nonclinical Biomedical Product Regulation
Course List | Code | Title | Hours |
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6405 | Nonclinical Regulations in Biomedical Product Commercialization | 4 |
| RGA 6420 | Global IVD Regulations and Submissions | 4 |
Quality Assurance Compliance
Course List | Code | Title | Hours |
| 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 | |
| |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6234 | Risk Management: Compliance and Processes | 4 |
| RGA 6275 | Product Development and Process Validation | 2 |
| 4 |
| European Union Compliance Process and Regulatory Affairs | |
| Fundamentals of CMC Regulations and Methods | |
| Food Safety and Surveillance: Concepts and Applications | |
