Shelly Maximov

Background

About Shelly Maximov

Director of Preclinical and Regulatory Affairs | Senior Project Manager | Data Science I am leading the preclinical development and regulatory strategy for two core domains critical to the advancement of our company’s lead molecule. As Director of Preclinical and Regulatory Affairs, I am responsible for the design, execution, and alignment of nonclinical programs with global regulatory expectations. My role includes direct management of regulatory submissions, coordinating inputs across disciplines, and liaising with global health authorities to ensure compliance with international standards and timelines. This includes cross-functional project leadership, close collaboration with internal development teams and CROs, and end-to-end project oversight to ensure timelines, budgets, and milestones are met across complex and dynamic development programs. My academic background is B.Sc./Eng. in Pharmaceutical Engineering and M.B.A. specializing in Data Science. I bring a strategic mindset and operational precision to every stage of drug development, with an expertise in project management.