Program Overview:

Master's in Regulatory Compliance

Regulatory compliance is increasingly visible in healthcare, life science and clinical research arenas. As a result, career opportunities in regulatory compliance are multiplying for those with the kind of training students receive in the Master of Science in Regulatory Compliance (MSRC) program. An interdisciplinary professional program, Northwestern University’s part-time MSRC program addresses core areas of compliance, including risk management, quality and regulatory science, practices and enforcement, leadership and communication skills. The MSRC curriculum focuses on these core competencies while also stressing practical applications within the program’s three tracks: healthcare compliance, clinical research and quality and regulatory science. MSRC graduates are prepared to assume leadership positions in healthcare compliance, clinical compliance, and in quality and regulatory industries, including pharmaceutical, life sciences, food, and medical device industries. Even PhDs can significantly enhance their skill sets and find new professional opportunities in this increasingly important and sensitive field.

The program offers a thorough grounding in the interdisciplinary core competencies of regulatory compliance, including risk management, quality and regulatory science, leadership and communication skills. MSRC places a strong emphasis on practical application: courses are taught by industry experts — leading minds with extensive experience in navigating regulatory compliance challenges. MSRC’s partnership with Northwestern Memorial Hospital, the Northwestern University Feinberg School of Medicine and the Northwestern University Clinical and Translational Science Institute is another benefit, continuously feeding the program with the latest insights on healthcare, translational research and regulation.


The MSRC program was presented at the Clinical and Translational Science Award (CTSA) Consortium Steering Committee (CCSC) in December, 2013. The MSRC degree program abstract, Training the Clinical and Translational Workforce of Tomorrow, was selected from abstracts submitted by all sixty CTSAs nationally as one of eleven to be orally presented at the 2013 national meeting held in Washington, DC. The MSRC program successfully meeting one of the primary goals of the CTSA, to increase the skills of the clinical and translational research workforce and provide them with career pathways to retain them in industry and academia.

Program Goals

  • Utilize regulatory, risk management and quality systems to assure compliant healthcare, clinical research and pharmaceutical environments.
  • Interpret regulatory requirements and apply them to various roles in healthcare, clinical research and pharmaceutical industries.
  • Create systems and processes to assure compliant quality outcomes.

Program Tracks

Upon admission to the program, students choose one of the following tracks, designed to effectively develop industry expertise in these areas:

Regulatory Compliance Faculty Perspectives

Karriem S. Watson, MS, MPH
MS in Regulatory Compliance instructor and co-founder and co-president of AcaMED Clinical Research Associates. Watson is also a research manager in the neurosurgery department of a major teaching hospital. He also researches community engagement in clinical trials and protocol design, execution and recruitment.

Pamela Mason, MPH
MS in Regulatory Compliance instructor executive vice president for Mason Professional Services, LLC, an independent consulting organization that performs audits, inspections and compliance training for the pharmaceutical, biotech, academic and medical device industries. She is currently the quality and compliance consultant for Northwestern’s Global Health Foundations.

Curriculum Requirements

The Master of Science in Regulatory Compliance requires completion of 11 courses—four core courses, four track (elective) courses, one cross-elective track course, a leadership course and a capstone (498) or thesis (590) project. View curriculum details for this program. Current students should refer to curriculum requirements in place at time of entry into the program.

Core Courses:

  • LEADERS 481-0 Leadership
  • LEADERS 481-DL Leadership
  • MSRC 401-0 OR 401-DL Quality Systems for Regulatory Compliance
  • MSRC 401-DL Quality Systems for Regulatory Compliance
  • MSRC 405-0 Applied Research & Writing
  • MSRC 409-0 Introduction to Biostatistics
  • MSRC 435-0 OR 435-DL Risk and Decision Management
  • MSRC 435-DL Risk and Decision Management
  • MSRC 590-0 Thesis Research

Elective Courses:

  • CLIN_RES 400-0 Essentials of Initiating Clinical Research
  • CLIN_RES 401-0 Responsible Conduct of Research
  • CLIN_RES 403-0 Clinical Research Design and Methodology
  • HC_COM 410-DL Healthcare Regulatory Environment
  • HC_COM 410-DL Healthcare Regulatory Environment
  • HC_COM 411-0 HC Programs & Enforcement
  • HC_COM 413-0 Healthcare Billing Models and Systems
  • QARS 420-0 Practical Quality Management
  • QARS 421-0 Applied Quality and Regulatory Practices
  • QARS 425-0 Quality Assurance Project Management
  • QARS 450-0 Medical Device Regulations