The UCSF School of Pharmacy is launching a new Master of Science degree in Regulatory Science and Digital Innovation (RSDI) to prepare professionals to lead effective regulatory, research and development solutions that allow promising new medications and health technologies to reach patients safely.

The program, the first of its kind in the nation, arrives at a pivotal moment for the field. Advances in artificial intelligence, digital health, data science, and technology are rapidly changing how new therapies and medical devices are developed.

“The regulatory field is changing as quickly as the science and technology it oversees,” said Liang Zhao, PhD, program director and professor. “We need professionals who can anticipate what’s coming and respond effectively. This new program will equip them with the skills to develop innovative solutions across industry, health care, and government.”

The new master’s program builds on the School of Pharmacy’s longstanding expertise in regulatory science and drug development, including leading the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation since 2014 and the school’s Master of Science program in AI and Computational Drug Development and Discovery that launched two years ago.

Two program tracks to choose from

Applications for the new RSDI program open Sept. 1, with the inaugural cohort slated to begin July 2027.

The program offers two tracks tailored to a student’s current career stage and where they want to advance. An executive track is designed for mid- to senior-level professionals and leaders working in health care, industry or policy, while a foundational track is geared toward early-career professionals seeking to enter or pivot into regulatory science, biotech, or digital health. 

Across both tracks, the curriculum focuses on modern regulatory science, including artificial intelligence, Software as a Medical Device, digital health, and global regulatory frameworks. The coursework combines rigorous coursework with real-world application, preparing students to address evolving regulatory challenges.

“In my 30 years working in medical technology, the biggest bottleneck to great technology reaching patients has rarely been the science or engineering; it's been the ability to navigate regulation and translate innovation into something a regulator, a hospital, and a health care provider can all understand and trust,” said Ian Purdy, senior vice president of regulatory affairs at Intuitive Surgical and a member of the RSDI program’s executive committee.

“It's a rare skill set, and it's what UCSF's RSDI program is built to develop,” he added. “I'm genuinely excited about a program that treats regulatory expertise not just as a compliance function, but as a leadership discipline in its own right.”

Coursework with real-world application

Students will complete the master’s degree in four to five quarters depending on the track. The program combines advanced coursework with applied learning through either a master’s thesis for those in the executive track or a capstone project for foundational track students.

The program is administered by the school’s Department of Bioengineering and Therapeutic Sciences, and guided by an executive committee that includes leaders from major biotech and technology companies such as Genentech and Accumulus Technologies.

“Tomorrow’s leaders will need to bridge science, technology, and regulation, applying innovation responsibly to accelerate the development and delivery of safe, effective therapies to patients,” said Francisco Nogueira, CEO of Accumulus Technologies and a member of the RSDI program executive committee. “With its world-class scientific expertise, entrepreneurial ecosystem, and commitment to public health, UCSF is uniquely positioned to prepare graduates to lead this transformation.”