- Susan Carino
Susan Carino had been working as a project management consultant for Integrated Project Management Company, Inc. (IPM) for five years when she began taking courses in Regulatory Affairs in July 2011.
“Many of the projects I manage are regulatory submissions and involve interactions with the FDA and other various regulatory authorities around the world,” Carino says. “As a growth opportunity, my company paid for tuition reimbursement so I could get certified in regulatory affairs and gain more subject matter knowledge.”
Though Carino’s original goal was to learn more about the burgeoning field of medical devices, especially as it pertained to regulatory affairs, in time she decided to pursue a certificate in Regulatory Affairs.
“There are three components to the FDA: drugs, biologics, and medical devices/diagnostics. Most regulatory affairs professionals specialize in one of those three areas. What’s unique about this program is that it exposes [students] to knowledge about all three. I had checked out the program at UC Berkeley, but their program is missing out on medical devices, which is part of our client work in the Bay Area. Since IPM project management consultants are expected to work in all three areas, the UCSC Extension program was a perfect fit.”
Carino came to Extension with a unique background in both science and business, having already completed an M.S. in chemistry, an M.B.A., and PMP® certification in Project Management. She was pleased to find her newfound knowledge translated directly to her day-to-day work.
“There was very strong synergy between what I was learning in class and what I was doing in my current projects. I could have used this knowledge on earlier projects. It was this synergy that kept me motivated to keep going.”
She was especially impressed by how much she learned in the Drug Development Process course.
“I wanted to waive that class because I’ve been a professional in drug development my whole career—since 1996. But it was a required core course, so I finally took the class and actually learned a lot.”
Once she has completed the Regulatory Affairs program, Carino plans to sit for the Regulatory Affairs Certification exam so she can transition into becoming a regulatory affairs project management consultant, thus merging her two fields of expertise. As it is now, she can already apply new skills and knowledge to her work at IPM.
“[I’ve learned some] core competencies that I’ll apply to future projects, such as submitting a 510(k) to the FDA. [Thanks to courses like] Regulatory Submissions: Devices and Diagnostics, I’ll be well positioned, should I be placed on a project to do that.”
Read more UCSC Extension Student Stories.