Kanpur, Uttar Pradesh, India
Experienced professionals with a strong background in ROW (Rest of the World) markets, including Asian, CIS, and African. Proficient in Microsoft Office applications, with practical knowledge of CTD/ACTD dossier preparation and submission processes. Well-versed in ICH guidelines, ensuring compliance and quality in pharmaceutical documentation and regulatory affairs.
• Dossier Preparation and Compilation for dosage form like Tablet, Capsule ,suspension and Injection (Biological and Non Biological). • Review drug master file (DMF)and other Document from the Plant. • Review Technical Documents of Product part (MFR, PDR,PVP/PVR,AMVP/AMVR,STS,STP and COA). • Review and arrange Artwork, other certificate and Document according to Ministry requirement of different Countries. • Coordination with other departments like F&D, QA, Plant and Project management for Various Regulatory Document for CTD/ACTD Dossier submission for countries. • Working For ROW Countries (TANZANIA, UGANDA , GHANA and MOZAMBIQUE)and ASEAN Country (MAYANMAR). • Review and respond to all product queries.
Quality control chemist