The Master of Science in Regulatory Science and Digital Innovation (RSDI) prepares professionals to lead at the intersection of health care innovation, digital technology, and global regulation. The program focuses on modern regulatory science, including artificial intelligence, Software as a Medical Device (SaMD), digital health, and global regulatory frameworks, combining rigorous coursework with real-world application to address evolving regulatory challenges.
Our program is designed for:
- Mid- to senior-level professionals looking to advance their leadership and strategic expertise in international regulatory affairs
- Early-career professionals or recent graduates seeking foundational training in digital and global regulatory science
- Individuals working or aspiring to work in biotech, pharma, medtech, digital health, policy, or regulatory agencies
I am genuinely excited about a program that treats regulatory expertise not just as a compliance function, but as a leadership discipline in its own right. I look forward to seeing what the graduates of the RSDI program can contribute to advancing health care around the globe.
Why UCSF?
- World-leading health sciences university
- Deep partnerships with industry, government, and global institutions
- Access to cutting-edge research, clinical trials, and real-world health data
- Located in the San Francisco Bay Area, a global hub for biotech and innovation
Program Highlights
- First-of-its-kind MS program in the U.S. focused on digital and global regulatory innovation
- Strong emphasis on AI, machine learning, digital health, cloud-based data systems, and real-world evidence
- Two flexible tracks to meet students where they are in their careers
- Taught by world-class UCSF faculty and industry experts
- Hands-on learning through case studies, workshops, and applied projects
- Built-in focus on ethics, health equity, and global public health
What You’ll Learn
Students develop expertise in:
- U.S. and global regulatory frameworks
- Drug, biologic, device, and digital health development
- AI and automation in regulatory decision-making
- Software as a Medical Device (SaMD)
- Quality assurance and compliance
- Regulatory strategy for clinical trials and real-world data
- Ethics and public health impacts of regulation
- Leadership, entrepreneurship, and cross-sector collaboration
Two Tracks Available
The RSDI program combines advanced coursework with applied learning through either a master's thesis or capstone project, depending on track. Students select one of two tracks at admission:
| Executive Track | Foundational Track | |
|---|---|---|
| Format | Hybrid: Online with in-person sessions during the first week of each quarter | Full-Time, In-Person |
| Duration | 5 quarters | 4 quarters |
| Units | 41.5 | 54.5 |
| Audience | For mid- to senior-level professionals looking to gain expertise in the global regulatory landscape and policy. Applicants are recommended to have 5-10 years of experience in healthcare or industry as entrepreneurs, managers, and/or executives. | For students aiming for careers in industry and regulatory affairs, or early-career professionals looking to transition into industry and regulatory work. Applicants should have a strong interest in digital regulatory science and health technologies |
| Curriculum | Culminates in a final master's thesis | Culminates in a capstone project |
Who Should Apply
- Students with backgrounds in life sciences, engineering, public health, data science, pharmacy, or related fields.
- Professionals looking to advance or transition into regulatory leadership.
- Applicants passionate about shaping the future of health care innovation and access.
- No GRE required. Holistic admissions review.