Northeastern University
Clinical Research Regulatory Affairs
Overview
The Graduate Certificate in Clinical Research Regulatory Affairs at Northeastern University builds practical expertise in how clinical research is regulated across major global markets. You’ll learn how to interpret regulatory requirements, support compliant trial operations, and help protect participant safety. Students gain a global perspective through coursework focused on FDA and international regulatory frameworks, with opportunities to connect with an alumni network working in pharmaceuticals, biologics, medical devices, and related industries. Unique features Develop regulatory and compliance skills used in clinical trial planning, documentation, and oversight. Study alongside an international cohort and learn how regulatory expectations can differ by region. Build toward further study: stack credits from this certificate toward Northeastern’s Master of Science in Regulatory Affairs (where applicable). Visa-eligible at Northeastern University campuses in the United States and Canada (eligibility depends on your location and circumstances).
About this programme
Overview
The Graduate Certificate in Clinical Research Regulatory Affairs at Northeastern University equips students with essential knowledge and skills in the regulation of clinical research across key global markets. This program emphasizes the interpretation of regulatory requirements, the support of compliant trial operations, and the safeguarding of participant safety.
Students will gain a comprehensive global perspective through courses that focus on both FDA and international regulatory frameworks. The program also offers opportunities to connect with a robust alumni network in pharmaceuticals, biologics, medical devices, and related sectors.
What you'll study
- Develop regulatory and compliance skills applicable to clinical trial planning, documentation, and oversight.
- Engage with a diverse international cohort to understand how regulatory expectations vary by region.
- Advance your education: credits from this certificate can be applied toward Northeastern’s Master of Science in Regulatory Affairs, where applicable.
- Eligibility for a student visa at Northeastern University campuses in the United States and Canada (conditions may apply based on your location and circumstances).
Programme Structure
The Graduate Certificate comprises graduate-level courses that transition from foundational regulatory concepts to applied clinical trial compliance and international regulatory operations.
- Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
- Medical Device Regulation
- Validation and Auditing of Clinical Trial Information
- Clinical Trial Design Optimization and Problem Solving
- Managing International Clinical Trials
Curriculum note: Course availability and sequencing may differ by campus and term. For the latest curriculum details, please refer to the programme website.
Entry requirements
Currently, there are no specific GRE or GMAT requirements for this programme, and specific GPA thresholds are not outlined in the available programme information.
Career prospects
Graduates of the Graduate Certificate in Clinical Research Regulatory Affairs can pursue various career opportunities in the pharmaceutical and healthcare industries. Roles may include regulatory affairs specialists, clinical trial managers, and compliance officers, among others. The comprehensive training provided in this programme prepares students to excel in diverse regulatory environments and contribute effectively to clinical research initiatives.
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