Devi L. Email & Phone Number

• Industry experience with major Pharmaceutical, High-tech and Biotechnology companies.• Experience in Regulatory Publishing using eCTDXPress, ISI Publisher, Insight Publisher and Core Dossier.• Experience in Documentum, with heavy experience in Regulatory Publishing Systems.• Working knowledge using Liquent's EZSubs Publishing Tool.• Thorough knowledge on 21 CFR part 11, FDA, GMP, GCP and GLP standards.• Thorough Knowledge of document management technology and electronic publishing.• Working knowledge of ISI Toolbox, Adobe-Toolbox, Microsoft Word, Excel, and PowerPoint.• Good Knowledge of Global Regulatory Affairs.• Familiar with ISI Toolbox, Documentum, EZSubs, eCTDXPress and/or and eCTD Viewer Tool, Regulatory & Compliance Document Formatting Standards.• Ability to deliver large NDA & BLA Submissions within the short deadlines