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Sue Manley has over 25 years of pharmaceutical industry experience and has been consulting for 5 years. Her most recent corporate experience was as Global Head of Regulatory Operations for Novartis Pharmaceuticals. She has a broad knowledge of the workings of the pharmaceutical industry with a focus on design and implementation of organizational processes to create harmony and efficiency across conflicting and inconsistent technical, cultural and geographic environments. Her experience includes managing transitions mandated by new regulatory requirements or company changes such as in or out licensing and mergers. She has directed staff to manage world-wide regulatory submission preparation, coordinate due diligence and legal depositions and oversee outsourcing. Her strong people skills have allowed success in team oriented “must do” environments. Most recently, as a consultant she has managed IND preparation for two non-US companies in an all remote environment. She also worked with a client to set and implement the strategy for a Rare Pediatric Voucher application that resulted in the awarding of the voucher. She has a MS degree from Seton Hall University in Biology/Business and a BS degree from Indiana University in Biology.