Regulatory Affairs Masters Program

Program Overview (online, part-time only)

The rapidly expansion of pharmaceutical and biomedical products requires a greater number of highly skilled Regulatory Affairs professionals to oversee the approval for new products lines and manage compliance with complex regulatory policies and procedures. Specialized and convenient education is crucial for busy professionals to develop and sustain an understanding of the ever-changing regulatory environment. The Masters of Science for Regulatory Affairs Program assures a strong professional background needed to succeed in administrative positions and specialized areas required of hands-on profession. This program is for individuals with a clear objective to cultivate a career in regulatory affairs and those with an industry background desiring advanced education in regulatory management. The Masters of Science for Regulatory Affairs Program covers regulatory requirements for Pharmaceutical, Biologic, Medical Device, Animal Health, International Regulations, and Combination Products.

  • Pharmaceuticals
  • Biologics
  • Medical Devices
  • Veterinary Products
  • Combination Products
  • International Regulations

Master's Program Plan

38-39 total semester hours (Thesis and Project options)
Course topics include the 14 semester hours in the RA Certificate Program:

  • Intro to Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • Food and Drug Law (3 hrs)
  • Current Good Manufacturing Practices (4 hrs)
  • Ethics in Research (3 hrs)

Additional core courses:

  • Quality Control & Quality Assurance (3 hrs)
  • Process Control & Validation (3 hrs)
  • Biostatistics (3 hrs)
  • FDA Applications & Submissions (4 hrs)
  • Master’s Thesis or Major Project

Advanced electives are:

  • Research Regulatory Affairs
  • Quality Control & Quality Assurance
  • Internship in Regulatory Affairs
  • Clinical Trials Design & Monitoring
  • Clinical Trials Project Managment
  • Developing Leadership Skills
  • Drug Development
  • Veterinary Products

Sample part-time schedule (for one academic term)

Fall Semester

  • PHAR 6100: Quality Assurance & Quality Control
  • PHAR 6200: Clinical Trials Design & Monitoring

Spring Semester

  • PHAR 6800: Applied Project
  • PHAR 6130 : FDA Submissions

Summer Semester

  • PHAR 7100: Biostatistics
  • PHAR 6210: Project Management for Clinical Trials