Katherine Hardwick

Katherine Hardwick is a Global Submission Manager at Vertex Pharmaceuticals, where experience spans from November 2015 to the present, progressing from Associate to Senior Manager within the Regulatory Project Management team. Key responsibilities include leading complex project plans, managing regulatory submissions for gene therapy and small molecule products, and coordinating interactions with agencies such as the FDA and EMA. Prior roles include Coordinator II and Administrative Assistant to the Vice President of Regulatory Policy & Operations, focusing on project management and administrative support. Earlier career experiences include roles at University of Phoenix and Heritage Environmental Services, highlighting expertise in student enrollment, retention strategies, and chemical de-packaging. Katherine holds a Bachelor's Degree in Biology from Drury University.