Student at graduation

KGI Graduates Explore Regulatory Affairs Careers at Gilead Sciences

Stephanie Sakamoto, MBS ’13, and Ashley Rhoades, MBS ’16, left Keck Graduate Institute (KGI) seeking careers in regulatory affairs. They’re off to a strong start after participating in a regulatory affairs rotational program at Gilead Sciences Inc., a leading research-based biopharmaceutical company headquartered in Northern California.

Sakamoto had completed a market research–focused Team Master’s Project (TMP) for Gilead as a KGI student and saw the company’s rotational program as an opportunity to dive deeper into regulatory affairs. She explains, “I had done a three-month internship with Regeneron but didn’t know all the ins and outs of regulatory affairs, so the rotations enabled me to see the different roles and projects in the department.”

During the two-year rotational program, Sakamoto gained exposure to regulatory compliance, including internal and external audits. She also helped manage FDA submissions and coordinated the filing of an investigational new drug application.

Now Sakamoto is an associate manager in the regulatory affairs labeling group, where she helps maintain Gilead’s core data sheet, which informs local product labeling and prescribing information. Sakamoto explains, “The label is a powerful way for us as a company to communicate with physicians and patients about drug safety, efficacy, and potential drug interactions. We’re able to provide important information and, as a team, we take that very seriously.”

Her KGI education has proven valuable in executing this responsibility. Sakamoto explains, “The beauty of a KGI education is that you get to specialize, but you also get a broad overview. So now I have a big-picture understanding of other functions within the company, which helps me bring something unique to the table. In this role, we have to be able to speak the language of the different functional areas and know the basics of each one.”

She also draws on workplace skills she was able to develop at KGI. Sakamoto explains, “As an undergraduate, I didn’t learn how to run a meeting, do an agenda, or even how to write an email in a business environment. KGI offered the opportunity to refine my professional skills. Now that I’m at Gilead, I realize how valuable that is.”

Sakamoto was among the first KGI graduates to participate in Gilead’s regulatory affairs rotational program and has seen many others follow. They include Rhoades, who arrived in 2016. Rhoades is currently working on clinical study reports in a medical writing rotation, the final one before her permanent placement. Earlier, she rotated through Gilead’s regulatory chemistry and manufacturing controls, regulatory compliance, and liver disease therapeutic area liaison regulatory affairs groups.

“I’ve been really surprised by how much I’ve enjoyed each rotation. Every subspecialty has so much to offer and is incredibly interesting. I get to work with really smart people and learn so much from them,” says Rhoades, whose desire to work in regulatory affairs stems from her interests in law and patient access to medicine. “I definitely see myself continuing in regulatory affairs, with the subspecialty to be determined.”

She also appreciates the strong KGI alumni network she’s found at Gilead. Rhoades explains, “I’ve been able to reach out to other alumni to have coffee or pick their brains. Now I talk with the newest rotational associates. When someone did that for you a year before, you want to pay it forward.”