Speakers

Sarah is currently an Associate Director, Regulatory Affairs Strategy and Science, Biosimilars at Sandoz. In this role, Sarah coordinates US regulatory submissions and strategies for Sandoz’s portfolio of biosimilar products. Sarah came to Sandoz after a successful career at FDA’s Center for Drug Evaluation and Research (CDER).

During her 12+ years in CDER, Sarah served in various Regulatory Project Management roles. She first joined the Office of Surveillance and Epidemiology (OSE), where she successfully led OSE’s project management efforts in navigating and standardizing processes for the Agency’s first 3 biosimilar products. Shortly thereafter, she transitioned to a team leader role, advising team members in managing projects across Office of New Drug (OND) therapeutic divisions. Following OSE, Sarah transitioned to the Office of Therapeutic Biologics and Biosimilars (OTBB), where she made major outstanding contributions to the biosimilars program. She functioned as project management team leader, creating a team and a new onboarding program from the ground up. She also led efforts to develop OTBB work processes, supported Biosimilar User Fee Reauthorization (BsUFA III) program changes, provided CDER-wide trainings on BsUFA III, and contributed to multi-disciplinary teams across all OND therapeutic divisions with biosimilar products throughout their lifecycle.

Before beginning her career in Regulatory Affairs, Sarah worked as a retail pharmacist at Rite Aid and as a healthcare consultant, advising on telemedicine state laws, which were up and coming at the time, and NCQA PCMH accreditation procedures.

Sarah earned her PharmD from the University of Pittsburgh School of Pharmacy and a graduate certificate in Project Management from the George Washington University. She currently lives in Frederick, MD with her husband and 2 young children.