The Master of Science in Regulatory Affairs (MSRA) is a two-year Keck Graduate Institute (KGI)–City of Hope (COH) joint program. The MSRA aims to provide students with translational and applied experience in regulatory affairs for all FDA-regulated product classes (drugs, biologics, and devices) throughout the product lifecycle (pre-clinical development, clinical development, and post-marketing).

Students take courses at KGI in the first year of the program, and in the second year, they complete two three-month rotation projects at COH.

Graduates will be uniquely positioned to begin careers in regulatory affairs and quality assurance for biotech and pharma companies, academic research, programs with regulatory functions, or continue onto doctorate programs in regulatory affairs.

This master’s is also a career change program for current employees in quality control or quality assurance.

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Industry-focused courses

In year one, students take rigorous graduate-level courses in applied biomedical sciences at KGI.

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Translational research projects

In year two, students conduct two three-month rotation projects at COH, gaining exposure to a multitude of regulatory affairs practices.

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In-depth experiential opportunities

Students interact with multiple regulatory and operational bodies that oversee regulatory and clinical trial activities.

What is regulatory affairs?

Regulatory affairs deal with the government and Food and Drug Administration quality and performance standards, ensuring that the therapeutics, devices, and other healthcare tools abide by such standards.

Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development.

In the drug, medical device, and biologic product industries, these phases include:

  • Research and development
  • Clinical trials
  • Regulatory submissions
  • Manufacturing
  • Marketing, distribution
  • Reimbursement
  • Post-market surveillance

In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.

$150,422

Average yearly salary for regulatory professional

40%

increase in job listings in the past four years

8%

Projected industry growth until 2026

What can I do with this degree?

There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:

  • Regulatory affairs specialist
  • Regulatory affairs manager
  • Regulatory affairs director
  • Compliance specialist
  • Food safety inspector
  • Clinical research associate
  • Director of quality assurance

MSRA learning objectives

  • Develop a thorough understanding of the regulatory review steps in the life of a clinical trial protocol, from concept review to submission to the FDA
  • Strengthen the understanding of regulatory strategy and review processes, from INTERACT or pre-IND to IND submission to the FDA
  • Write a clinical trial protocol starting from a template
  • Assess the literature, identify knowledge gaps, and convey findings to the scientific community
  • Communicate effectively in an industry environment composed of scientists, engineers, and business professionals
  • Contribute productively on an interdisciplinary team tackling complex problems

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