Regulatory Affairs, MS (Online)

Graduatemajor2027 catalogProfessional StudiesOnline34 semester hours totalverified parse

Official catalog page for this program

Required Courses

• RGA 6105 — Introduction to Regulatory Compliance and Practice
• RGA 6150 — Regulatory Strategy for Product Development and Life-Cycle Management
• RGA 6208 — Introduction to Safety Sciences
• RGA 6238 — Human Experimentation Methodological Issues Fundamentals
• One of:
  • RGA 6308 — Pharmaceutical and Medical Device Law: Topics and Cases
  • RGA 6350 — Legal Issues in International Food, Drug, and Medical Device Regulation

Restricted Electives

From the catalog

Complete 4 semester hours from the following:

• Choose 4 semester hours from:
  • RGA 6400 — Medical Device Product Development and Process Validation
  • RGA 6415 — Fundamentals of CMC Regulations and Methods
  • RGA 6435 — Medical Device Cybersecurity and Digital Health
  • RGA 6440 — Advanced Topics in Advertising and Promotion of Drugs and Medical Devices
  • RGA 6450 — Financing and Reimbursement in Biomedical Product Development
  • RGA 6465 — Nonclinical Regulations in Biomedical Product Commercialization
  • RGA 6475 — Strategic Planning and Project Management for Regulatory Affairs
  • RGA 6480 — Real-World Evidence and Patient-Reported Outcomes in Regulatory Decision Making
  • RGA 6490 — Emerging Trends and Challenges in Regulatory Affairs
  • RGA 6500 — Biomedical Product Development: Regulatory Affairs in a Market-Based Setting

Capstone

• RGA 6980 — Capstone: Practical Applications in Global Regulatory Affairs

Concentrations

Biopharmaceutical Regulatory Affairs

• RGA 6600 — Introduction to Food and Drug Administration Pharmaceutical Regulation
• RGA 6660 — Therapeutic Product Development: A Regulatory Overview
• RGA 6670 — Global Impact of Electronic Common Technical Document (eCTD) Submissions
• RGA 6680 — Project Management in Early Drug Discovery and Development

Clinical Research Regulatory Affairs

• RGA 6285 — Validation and Auditing of Clinical Trial Information
• RGA 6290 — Clinical Trial Design Optimization and Problem Solving
• RGA 6295 — Managing International Clinical Trials
• One of:
  • RGA 6600 — Introduction to Food and Drug Administration Pharmaceutical Regulation
  • RGA 6610 — Introduction to Food and Drug Administration Medical Device Regulation

Global Regulatory Affairs

• RGA 6650 — Medical Device Product Development in Canada
• RGA 6675 — Therapeutic Product Development in Canada
• RGA 6685 — European Medical Device Regulations
• RGA 6690 — Global In Vitro Diagnostic Regulations and Submissions

Medical Device Regulatory Affairs

• RGA 6610 — Introduction to Food and Drug Administration Medical Device Regulation
• RGA 6620 — Medical Device Development: A Regulatory Overview
• RGA 6630 — Medical Device Quality Management System: Principles and Applications
• RGA 6640 — Risk Management: Compliance and Processes

GPA requirements

• 34 total semester hours required Minimum 3.000 GPA required

Parsed from the catalog by NU Map; the structured machine copy is in this college's JSON for the 2027 catalog, under regulatory-affairs-ms-online, and the official page is the authority.