Regulatory Affairs professional with 8+ years of experience in authoring CMC sections for various drug product registrations to CDSCO, WHO, ROW markets and many drug substance dossier submissions to US, EU, HC, EDQM and China regulatory authorities. Having diverse professional experience in regulatory submissions, compliance, and maintenance of product licenses and technical writing of CMC sections in both Biotech and Pharmaceuticals industries. Can Author and/or review high-quality CMC documentation for any Health Authority (HA) submissions by applying current regulatory guidelines.