Stephanie Sakamoto, MBS 鈥�13, and Ashley Rhoades, MBS 鈥�16, left 蜜桃直播 (蜜桃直播) seeking careers in regulatory affairs. They鈥檙e 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鈥揻ocused Team Master鈥檚 Project (TMP) for Gilead as a 蜜桃直播 student and saw the company鈥檚 rotational program as an opportunity to dive deeper into regulatory affairs. She explains, 鈥淚 had done a three-month internship with Regeneron but didn鈥檛 know all the ins and outs of regulatory affairs, so the rotations enabled me to see the different roles and projects in the department.鈥�
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鈥檚 core data sheet, which informs local product labeling and prescribing information. Sakamoto explains, 鈥淭he 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鈥檙e able to provide important information and, as a team, we take that very seriously.鈥�
Her 蜜桃直播 education has proven valuable in executing this responsibility. Sakamoto explains, 鈥淭he beauty of a 蜜桃直播 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.鈥�
She also draws on workplace skills she was able to develop at 蜜桃直播. Sakamoto explains, 鈥淎s an undergraduate, I didn鈥檛 learn how to run a meeting, do an agenda, or even how to write an email in a business environment. 蜜桃直播 offered the opportunity to refine my professional skills. Now that I鈥檓 at Gilead, I realize how valuable that is.鈥�
Sakamoto was among the first 蜜桃直播 graduates to participate in Gilead鈥檚 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鈥檚 regulatory chemistry and manufacturing controls, regulatory compliance, and liver disease therapeutic area liaison regulatory affairs groups.
鈥淚鈥檝e been really surprised by how much I鈥檝e 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,鈥� says Rhoades, whose desire to work in regulatory affairs stems from her interests in law and patient access to medicine. 鈥淚 definitely see myself continuing in regulatory affairs, with the subspecialty to be determined.鈥�
She also appreciates the strong 蜜桃直播 alumni network she鈥檚 found at Gilead. Rhoades explains, 鈥淚鈥檝e 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.鈥�