Nicole MacAlena

Nicole Macalena is an experienced Regulatory Affairs Project Manager at Padagis LLC, with a career spanning over a decade, starting in November 2011. In this role, Nicole oversees regulatory activities throughout the lifecycle of NDA, ANDA, and OTC products, facilitating submissions, approvals, and product launches while maintaining commercial drug products. Previously, Nicole served as an Associate Scientist, focusing on quality control laboratory process improvements. Early career experience includes roles as a Senior Chemist at HVL, LLC, managing an analytical QC lab, and as an Analytical Chemist and Lab Supervisor at Pace Analytical at 3M, specializing in transdermal product development. Nicole also has coaching experience as an assistant pole vault coach at St. Catherine University. Academic qualifications include dual B.A. degrees in Chemistry from Saint John's University and the College of Saint Benedict, and coursework at the University of Wisconsin-Madison.