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...
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