/ http://www.slideshare.net/images/logo.gif / 際際滷Share feed for 際際滷shows by User: draprofessional https://cdn.slidesharecdn.com/profile-photo-draprofessional-48x48.jpg?cb=1602052890 1. Submission Management for various EU/US submissions for technically valid and timely dossier submissions to Health Authority(s), along with the development and implementation of the regulatory strategies for Pharmaceuticals and drug-device combination products. 2. CMC Writing & Review, CTD filling (Paper filling), eCTD filling (electronic submission), devising Regulatory Strategies, Document Management System, SOP & workflow writing and Review, Regulatory Compliance, Regulatory Liasion, Pharmacopeial Compliance Initiatives & People Management. 3. Expertise in dossier preparation & updating of registration dossiers in E-CTD format using Insight Publisher, eCTD Xpress, ISI Publisher a...