Regulatory Science, MS

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— Advanced education without prior work experience

Learn the skills you need to excel in the global regulatory field.  Our MS in Regulatory Science prepares you to tackle the challenges facing the clinical field by emphasizing a transdisciplinary approach to meet the unique needs of regulating bodies and the regulated industry.  But unlike other master’s degrees, the MS Regulatory Science doesn’t require prior work experience, so graduates can enter the workforce better prepared than ever before.  This 33-credit program exposes graduates to the legal and ethical aspects that make up clinical research and medical device development, as well as safety in regulatory science, regulations throughout the life cycle of medical products and the drug-approval process.

Key areas of emphasis

  • Ethics, quality systems, legal aspects in the global regulatory field.
  • Clinical research procedures and regulations in drug and device trials
  • Safety as a fundamental aspect of regulatory science


The MS program in regulatory science is designed to prepare students for careers in the field of regulatory affairs. It focuses on safety as a fundamental aspect of regulatory science, the application of regulations throughout the life cycle of medical products, and compliance with regulations in the development, approval and marketing of medical products. The program incorporates a transdisciplinary approach to meet the unique needs of regulating bodies and the regulated industry. It encompasses coursework in clinical research, ethics, quality systems, legal aspects and global regulatory affairs in the regulatory field.

Program Offered

Regulatory Science, MS

Offered by
Edson College of Nursing and Health Innovation

Downtown, Online

Plan of Study

The Plan of Study is the required curriculum to complete the program.

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Application Deadline

This degree follows the general graduate application deadlines.

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Financing Your Education

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Financial Aid
ASU has many financial aid options. Almost everyone, regardless of income, can qualify for some form of financial aid. In fact, more than 70 percent of all ASU students receive some form of financial assistance every year.

Program Requirements

Required Core (18 credit hours)
HCR 553 Quality Assurance and Clinical Research (3)
HCR 561 Responsible Conduct of Clinical Research (3)
HCR 563 Fundamentals of Regulatory Affairs (3)
HCR 576 Drug Discovery, Development and Regulations (3)
HCR 577 Global Regulatory Affairs (3)
HCR 578 Legal Aspects of Clinical Research (3)

Restricted Electives (12 credit hours)
HCR 552 Medical Device Development and Regulation (3)
HCR 555 Pharmaceutical Safety and Risk Management (3)
HCR 557 Clinical Research Design and Methods (3)
HCR 558 Technical Writing for the Regulatory Professional (3)
HCR 564 Global Regulatory Affairs Leadership (3)
HCR 568 Health Care Project Management (3)
HCR 575 Contracting and Budgeting for Industry-Sponsored Clinical Trials (3)
HCR 579 Translational Research in Drug Discovery and Development (3)

Culminating Experience (3 credit hours)
HCR 593 Applied Project (3)

Additional Curriculum Information
For electives coursework, students choose four courses for 12 credit hours from the restricted electives list. Other coursework may be substituted with approval from the academic unit.

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