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 for students interested in protecting public health by controlling the distribution of products such as pharmaceuticals, medical devices, as well as agrochemicals. In particular, the ASU regulatory science program focuses on drugs and devices, preparing students for careers in the pharmaceutical, medical research and medical device industries.

The field of regulatory science focuses on the application of regulations throughout the lifecycle of medical products and compliance with regulations in the development, approval and marketing of medical products. This advanced degree incorporates a transdisciplinary approach to meet the unique needs of regulating bodies and the industry. While earning the Master of Science in regulatory science, students delve into all aspects of regulatory affairs including clinical research, ethics, quality systems, legal aspects and global regulatory practices in the regulatory field.

At A Glance

Regulatory Science, MS

Plan of study

The Plan of study is the required curriculum to complete this graduate level program.

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Application Deadline

This degree follows the general graduate application deadlines.

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Information Sessions

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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.

Degree 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 Management and Negotiation of Clinical Trial Budgets and Contracts (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.

Admission requirements

Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.

Applicants are eligible to apply to the program if they have earned a bachelor's or master's degree from a nationally recognized, regionally accredited academic institution.

Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in the last 60 hours of their first bachelor's degree program, or applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.

All applicants must submit:

  1. graduate admission application and application fee
  2. official transcripts
  3. resume or curriculum vitae
  4. two online recommendations
  5. personal statement
  6. proof of English proficiency

Additional Application Information
An applicant whose native language is not English must provide proof of English proficiency regardless of current residency.

The online references should be from professional colleagues, supervisors, professors or other professional contacts and should attest to the applicant's academic and leadership experiences.

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What are ASU's Online Programs?

ASU Online offers programs like Regulatory Science, MS in an entirely online format with multiple enrollment sessions throughout the year.

More information on the program is available directly from ASU Online.