Jennifer Harakal is Head of the U.S. Regulatory Affairs Practice at ELIQUENT Life Sciences, where she leads strategic regulatory initiatives across the biotech, pharmaceutical, and medical device industries. She brings over 20 years of regulatory experience with deep expertise spanning medical device regulatory strategy, advertising and promotional review for both drugs and devices, and the leadership of high-performing consulting practices.

Prior to joining ELIQUENT, Jennifer served as the Head of Regulatory Affairs at Canopy Life Sciences where she built a full-service consultancy from the ground up. She led business development, expanded the regulatory team, and drove cross-functional regulatory practices covering strategy, labeling (strategy and operations), and CMC, while maintaining a hands-on role in advertising and promotion. Before Canopy, Jennifer spent over a decade at Opus Regulatory leading regulatory consulting practices serving the biopharmaceutical and medical device sectors. She built and managed high-performing teams, supported business growth, and remained actively engaged in client work in advertising and promotion while overseeing broader regulatory areas including strategy, labeling, and CMC.

Jennifer began her career in hands-on regulatory roles at Sanofi, Zimmer, Biomet, Stryker, Datascope, and B. Braun, gaining broad experience across drug and device portfolios. In 2012, she transitioned into consulting, combining technical expertise with strategic leadership to support clients around the globe.

Throughout her career, Jennifer has demonstrated a commitment to building collaborative, results-oriented teams and delivering exceptional client service while maintaining the highest standards of regulatory and operational excellence.