MS in Regulatory Affairs
Course Overview
Northeastern University's STEM-designated Master of Science in Regulatory Affairs prepares you to manage the complex process of bringing highly regulated products to global markets. This program deepens your expertise in the compliance requirements for food, drugs, biologics, and medical devices. Based in the life sciences hub of Boston, it is designed for professionals seeking to advance their careers in this high-demand field.
Key Program Highlights
- STEM-designated graduate degree enhancing technical and analytical skills
- Comprehensive curriculum covering global compliance for drugs, biologics, medical devices, and food products
- Industry-aligned program located in Boston, a premier hub for life sciences and technology
- Focus on managing the entire product lifecycle from development to market approval and beyond
- Designed to prepare students for leadership roles in a high-demand profession
Course Overview
Northeastern University's STEM-designated Master of Science in Regulatory Affairs prepares you to manage the complex process of bringing highly regulated products to global markets. This program deepens your expertise in the compliance requirements for food, drugs, biologics, and medical devices. Based in the life sciences hub of Boston, it is designed for professionals seeking to advance their careers in this high-demand field.
Key Program Highlights
- STEM-designated graduate degree enhancing technical and analytical skills
- Comprehensive curriculum covering global compliance for drugs, biologics, medical devices, and food products
- Industry-aligned program located in Boston, a premier hub for life sciences and technology
- Focus on managing the entire product lifecycle from development to market approval and beyond
- Designed to prepare students for leadership roles in a high-demand profession
Requirements
Modules
- Human Experimentation: Methodological Issues Fundamentals
- Introduction To Regulatory Compliance And Practice
- Pharmaceutical And Medical Device Law: Topics And Cases
- Legal Issues In International Food, Drug, And Medical Device Regulation
- Introduction To Safety Sciences
- Regulatory Strategy For Product Development And Life-Cycle Management
- Practical Applications In Global Regulatory Affairs
- 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
- Cybersecurity And Regulation Of Digital Health Technologies By The Fda
- Global Economics Of Food And Agriculture
- Sustainable Development
- Global Corporate Social Responsibility
- 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
- Medical Device Product Development In Canada
- Therapeutic Product Development In Canada
