Lara HansenĀ is a Director of Regulatory Affairs at Sandoz with more than 20 years of pharmaceutical regulatory experience across generic medicines, complex products, and drug-device combination products. Throughout her career, she has supported a diverse portfolio of products, including injectables, ophthalmic, nasal products, inhalation therapies, and other complex dosage forms.
In her current role, Lara leads a U.S. Regulatory Affairs team responsible for developing and executing regulatory strategies, managing lifecycle activities, and overseeing interactions with the U.S. Food and Drug Administration (FDA). She provides strategic regulatory leadership for cross-functional teams and guides products through key regulatory milestones, including ANDA and 505(b)(2) submissions, product approvals, post-approval changes, and compliance initiatives.
Lara earned a Bachelor of Science degree in Biochemistry from Colorado State University and is recognized for her expertise in navigating complex regulatory pathways and advancing product development programs in the U.S. market.