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.
Complete all courses and requirements listed below unless otherwise indicated.
Required Courses
Course List | Code | Title | Hours |
| RGA 6105 | Introduction to Regulatory Compliance and Practice | 3 |
| RGA 6150 | Regulatory Strategy for Product Development and Life-Cycle Management | 3 |
| RGA 6208 | Introduction to Safety Sciences | 3 |
| RGA 6238 | Human Experimentation Methodological Issues Fundamentals | 3 |
| RGA 6308 | Pharmaceutical and Medical Device Law: Topics and Cases | 3 |
| or RGA 6350 | Legal Issues in International Food, Drug, and Medical Device Regulation |
| 4 |
| Medical Device Product Development and Process Validation | |
| Fundamentals of CMC Regulations and Methods | |
| Medical Device Cybersecurity and Digital Health | |
| Advanced Topics in Advertising and Promotion of Drugs and Medical Devices | |
| Financing and Reimbursement in Biomedical Product Development | |
| Nonclinical Regulations in Biomedical Product Commercialization | |
| Strategic Planning and Project Management for Regulatory Affairs | |
| Real-World Evidence and Patient-Reported Outcomes in Regulatory Decision Making | |
| Emerging Trends and Challenges in Regulatory Affairs | |
| Biomedical Product Development: Regulatory Affairs in a Market-Based Setting | |
| RGA 6980 | Capstone: Practical Applications in Global Regulatory Affairs | 3 |
Concentration or Electives Option
A concentration is not required. Students may complete the electives option in lieu of a concentration.
Program Credit/GPA Requirements
34 total semester hours required
Minimum 3.000 GPA required
Biopharmaceutical Regulatory Affairs Concentration
Course List | Code | Title | Hours |
| RGA 6600 | Introduction to Food and Drug Administration Pharmaceutical Regulation | 3 |
| RGA 6660 | Therapeutic Product Development: A Regulatory Overview | 3 |
| RGA 6670 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 3 |
| RGA 6680 | Project Management in Early Drug Discovery and Development | 3 |
Clinical Research Regulatory Affairs Concentration
Course List | Code | Title | Hours |
| RGA 6285 | Validation and Auditing of Clinical Trial Information | 3 |
| RGA 6290 | Clinical Trial Design Optimization and Problem Solving | 3 |
| RGA 6295 | Managing International Clinical Trials | 3 |
| RGA 6600 | Introduction to Food and Drug Administration Pharmaceutical Regulation | 3 |
| or RGA 6610 | Introduction to Food and Drug Administration Medical Device Regulation |
Global Regulatory Affairs Concentration
Course List | Code | Title | Hours |
| RGA 6650 | Medical Device Product Development in Canada | 3 |
| RGA 6675 | Therapeutic Product Development in Canada | 3 |
| RGA 6685 | European Medical Device Regulations | 3 |
| RGA 6690 | Global In Vitro Diagnostic Regulations and Submissions | 3 |
Medical Device Regulatory Affairs Concentration
Course List | Code | Title | Hours |
| RGA 6610 | Introduction to Food and Drug Administration Medical Device Regulation | 3 |
| RGA 6620 | Medical Device Development: A Regulatory Overview | 3 |
| RGA 6630 | Medical Device Quality Management System: Principles and Applications | 3 |
| RGA 6640 | Risk Management: Compliance and Processes | 3 |
Electives Option
Course List | Code | Title | Hours |
| 12 |
Optional Experiential Learning Opportunities
The College of Professional Studies encourages its students to incorporate optional experiential learning opportunities in their academic plans.
Course List | Code | Title | Hours |
| |
| INT 6200 | Experiential Project Preparation | 1 |
| COP 6945 | Co-op Work Experience—Full Time | 0 |
| or COP 6946 | Global Co-op Work Experience—Full Time |
| or COP 6954 | Co-op Work Experience - Half-Time |
| |
| INT 6943 | Integrative Experiential Learning | 3 |
