Regulatory Science, MS

Program Overview

Arizona State University's Regulatory Science MS program empowers individuals to contribute to public health and drive innovation in the life-changing medical products industry. The program focuses on drugs and devices, preparing graduates for careers in regulatory affairs, with a comprehensive curriculum covering all aspects of the field. Students can complete the 33-credit program in-person or online, with multiple enrollment sessions available throughout the year.

Program Outline

Degree Overview:

Mission:

To empower individuals to contribute to society, protect public health, and drive innovation in the discovery, development, and marketing of life-changing products, from life-saving medicines to cutting-edge medical devices.

Program Focus:

This program prepares students for careers in the pharmaceutical, medical research, and medical device industries, with a specific focus on drugs and devices.

Learning Outcomes:

Graduates will be able to:

• Understand all aspects of regulatory affairs, including clinical research, drug and medical device development, ethical and legal aspects, global regulatory practices, and manufacturing regulatory submissions.
• Apply regulations throughout the life cycle of medical products and comply with regulations in the development, approval, and marketing of medical products.
• Contribute to the transdisciplinary approach required to meet the unique needs of regulating bodies and the industry.

Outline:

Structure:

The program requires 33 credit hours, including a required applied project course.

Required Core Courses:

• HCR 553: Quality Assurance and Clinical Research
• HCR 561: Responsible Conduct of Clinical Research
• HCR 563: Fundamentals of Regulatory Affairs
• HCR 576: Drug Discovery, Development and Regulations
• HCR 577: Global Regulatory Affairs
• HCR 578: Legal Aspects of Clinical Research

Restricted Electives:

Students choose four courses for 12 credit hours from the following list:

• HCR 552: Medical Device Development and Regulation
• HCR 555: Pharmaceutical Safety and Risk Management
• HCR 557: Clinical Research Design and Methods
• HCR 558: Technical Writing for the Regulatory Professional
• HCR 564: Global Regulatory Affairs Leadership
• HCR 568: Health Care Project Management
• HCR 575: Management and Negotiation of Clinical Trial Budgets and Contracts
• HCR 579: Translational Research in Drug Discovery and Development

Culminating Experience:

Careers:

Potential Career Paths:

• Compliance officer
• FDA inspector
• Quality assurance specialist
• Quality control specialist
• Regulatory affairs professional
• Regulatory coordinator
• Regulatory manager
• Regulatory scientist

Other:

• The program can be completed in-person or online.
• The program is offered in Downtown Phoenix.
• The program is offered in multiple enrollment sessions throughout the year.
• The program is designed for students who want to protect public health through the discovery, development, and marketing of medical products.

Additional Notes:

• This is a high-level overview of the program.