Courses at Northeastern University

Through Northeastern University's MS in Regulatory Affairs program, students have the opportunity to tailor their education to align with their career aspirations. The program allows students to specialise in essential domains of regulatory affairs, including operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance. By focusing on these areas, students can effectively pursue their professional objectives in the field of regulatory affairs.

Course Curriculum

The curriculum where the course syllabus includes:- 

1) Bio pharmaceutical regulatory affairs

2) Clinical Research Regulatory Affairs

3) Medical Device Regulatory Affairs

4) Nonclinical Biomedical Product Regulation

5) Quality Assurance and Compliance

Course Highlights

Admission Requirements

Exams

• Minimum GPA: 3.0
• IELTS: 6.5 overall
• Duolingo: 105

 Documents/Prerequisite

• Online Application
• The Purpose Statement 
• A résumé for professional purpose 
• Two letters of recommendation
• Proof of an official undergraduate degree 
• Work experience of two to three years 
• Evidence of English linguistic ability
• Unofficial transcripts of undergraduate work