Niels Buch Leander is heading NNIT’s Regulatory Affairs consultancy area and is part of the management group in NNIT’s Life Sciences Division. As a managing consultant, Niels is working on aligning business and IT within the Pharmaceutical Industry, with a special emphasis on Regulatory Affairs. Niels area of expertise includes: Regulatory tracking, xEVMPD ISO IDMP Regulatory document management, eCTD electronic submission and eTMF, Information Management in the pharmaceutical industry, Application Portfolio Management in the pharmaceutical industry or Cloud Computing in the pharmaceutical industry. Niels is TOGAF-certified as enterprise architect with a focus on building change in pharmaceutical organisations based on a solid business architecture and information architecture and holds a B.A. Honours from the University of Cambridge, an M.A. from the Sorbonne and a Ph.D. from Cornell University.