Northeastern University United States

Regulatory Affairs, MS

Integrated Masters with deeper specialization and research focus
Taught in English
Duration 12 Months
Mode On Campus
Level Postgraduate
Degree Masters Degree
Closing soon November 2026

Course Overview

The Master of Science in Regulatory Affairs at Northeastern University is designed for ambitious professionals aiming to navigate the complex global landscape of regulated products, including pharmaceuticals, medical devices, and food. As industries face evolving compliance requirements and technological advancements, this program equips you with the integrated knowledge and broad perspectives essential for managing regulatory processes from product conception through to market approval and lifecycle management. You will delve into critical areas such as pharmaceutical and medical device law, safety sciences, and international regulatory frameworks, preparing you to address the challenges of bringing highly regulated products to market effectively and ethically.

This full-time, on-campus Master's degree is structured over 12 months, providing an intensive and immersive learning experience. You will engage with core coursework covering essential regulatory compliance, human experimentation, and product development strategies, complemented by opportunities to specialize through concentrations in areas like Biopharmaceutical Regulatory Affairs or Medical Device Regulatory Affairs. The curriculum emphasizes practical application, culminating in a capstone project where you will tackle real-world regulatory challenges. Upon graduation, you will be prepared for impactful careers in regulatory affairs, quality assurance, and compliance within the life sciences and related industries.

Course Curriculum & Details

Detailed information for serious evaluators

Program Overview

The Master of Science in Regulatory Affairs program provides a comprehensive understanding of the complex regulatory landscape governing products such as pharmaceuticals, medical devices, and food. This program delves into critical areas including human experimentation, legal frameworks, international regulations, and safety sciences, preparing students for strategic product development and life-cycle management. Students will also engage in practical applications through a capstone experience and have the opportunity to tailor their studies with a variety of elective courses covering specialized topics and emerging trends.

1 Required Courses

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

2 Capstone

Practical Applications in Global Regulatory Affairs

3 Elective Courses

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

Cost & Affordability

A clear picture of what this course will cost you

Program Costs

First Year Fee Tuition fee
USD 42,525.00
Total Program Cost Estimated total tuition
USD 42,525.00

Currency note: Program costs shown in USD based on the available tuition breakdown.

Living Costs

Accommodation
USD 1,500.00 - USD 2,000.00
Food & Groceries USD 4,200.00 - USD 6,000.00
Transport USD 1,200.00 - USD 1,800.00
Utilities & Bills USD 1,440.00 - USD 2,400.00
Estimated Total USD 6,840.00 - USD 10,200.00

Living cost estimates are based on Boston Campus.

Outcomes & Employability

What happens after you graduate

96%
Graduate Employment Rate Within 6 to 12 months of graduation

Common Graduate Roles

Biotechnology & GenomicsClinical & Medical ServicesClinical Trials & DevelopmentDrug Discovery & ResearchHealthcare Administration & ManagementHealthcare ConsultingHome Health & Long‑Term CareMedical Devices & DiagnosticsPublic Health & EpidemiologyRehabilitation & Physiotherapy

Top Employers Hiring for this course

Boston Children's Hospital

Brigham and Women's Hospital

Massachussets General Hospital Boston

Why Study Regulatory Affairs, MS at Northeastern University

What makes this program stand out

November 2026 Closing soon

Next intake is in November 2026

Moderate Application response time

Northeastern University typically responds to applications within 1 - 2 weeks, giving you clarity on your options quickly.

Life at Northeastern University in United States

What daily life looks like for international students

Language

English

Primary language everywhere

Climate

Mild & Rainy

10-20°C average, pack layers

Safety (Numbeo Safety Index)

Very Safe

Exeter is one of UK's safest cities

Frequently Asked Questions

Common questions about Regulatory Affairs, MS at Northeastern University

Can I work while studying?

International students can work up to 20 hours a week during terms and full-time during breaks on campus. Off-campus work may be possible after the first year with university approval.

What English language score do I need for this course?

International students must meet specific English test requirements. Accepted tests include Duolingo, IELTS, and PTE with defined scores across various components.

What jobs can I get after studying this course?

Graduates can pursue job titles such as Regulatory Affairs Specialist, Compliance Manager, Quality Assurance Analyst, and Regulatory Affairs Manager.

What will I actually study in this course?

The Master of Science in Regulatory Affairs at Northeastern University covers global compliance requirements and the regulatory process for products like drugs and medical devices. This program equips students to manage product life cycles from discovery to commercialization.

When can I start — what are the intake months?

The Regulatory Affairs MS program has intakes in February, June, and November. Make sure to apply before these months to start your studies.
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