Creative, flexible and energetic leader adept at developing key talent, successfully delivering large-scale projects and navigating complex regulatory, technical and resourcing issues using sound judgment and 20 years of industry experience. Ability to strategically and creatively plan and deliver global marketing applications. Highly skilled at hiring, developing and leading large, top-performing eCTD submission publishing, planning and regulatory information management teams both on and off-shore. Proven ability to establish effective partnerships and influence Clinical, CMC, Medical Writing, Stats & Programming, PV & vendors to deliver right first time submission content as well as quantifiable, high-impact process improvements. Extensive experience leading Advisory Committee preparation activities ensuring flawless preparation and execution, as well as Health Authority submission review meetings to acclimate review teams with robust dossiers under accelerated review periods. Significant experience managing the regulatory activities to support mergers, acquisitions and divestitures including RIM, regulatory intelligence collection and execution of all related submission activity. Veeva Vault White Belt and Business Administrator Certified who played an integral part in multiple Vault installations and extensive expertise with submission planning, tracking, RIM and publishing tools and software.
Listed skills include Fda, Pharmaceutical Industry, Regulatory Requirements, Clinical Trials, and 25 others.