International Trade Specialist Develops Biotech Trainings After Completing Regulatory Affairs


- Gabriela Zelaya

Term : June, 2013
Department : Biosciences
Program : Regulatory Affairs

Gabriela Zelaya had been working for the U.S. Commercial Service as an international trade specialist focusing on healthcare and education when she started taking classes at UCSC Extension in 2009. A communications expert with experience in international affairs and marketing, her professional domain was expanding to cover the life sciences, including biotechnology and regulatory affairs, and she needed to build critical scientific vocabulary to meet the needs of her job. Extension’s Regulatory Affairs courses provided the foundation that she needed, not only to complete projects at work, but to establish a new biotech sub-team and spearhead exciting new projects.

“I cover the life sciences for our office in the Bay Area,” she says. “Our goal is to help small companies find partners overseas and generate revenues to then hire more people here in the U.S. I needed to be able to understand what my clients were saying, what challenges they were facing, and Extension’s classes definitely gave me that insight. My office paid for the first few classes, and then I liked the program so much that I decided to complete the certificate in Regulatory Affairs.”

Zelaya says that Extension’s courses were rigorous, covering everything from drug discovery and development to regulatory submissions, FDA approval processes and clinical trials.

“When people would reference PMA or other acronyms, I didn’t really understand what those were,” she says. “In class I learned what pre-market approval (PMA) was, as well as FDA licensing, and the lifespan of producing a pharmaceutical or biologic. I learned what our relationship is with the FDA, and the challenges there, and all of this knowledge resonated with what I was seeing at conferences. The professors were people in industry who knew what it was like being part of a life science company.”

 This knowledge was essential in helping her organize free webinars for American biotech specialists, a series produced through the Commercial Service as “Twenty-first Century Trade Specialist Trainings.” As a member of the healthcare team, she now heads a biotech sub-team responsible for briefing biotech professionals across the country. She even recruited a few of Extension’s instructors to participate in online panels and webinars.

 “I’ve been able to translate what I learned to real life, to how we support life science companies,” she says. “Completing the certificate really boosted my position in terms of knowledge in my industry; it made me the point person for biotech, and in the Bay Area, we represent biotech for the nation. The certificate was the next step in my career. I needed this extensive knowledge of the life sciences to be able to do all this.”

 Zelaya completed the certificate in Regulatory Affairs in 2010 and has since organized biotech trainings in San Jose, Washington D.C., and New York.

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