Naprod Life Sciences Pvt. Ltd requires an Assistant Manager in Regulatory Affairs with direct, hands-on experience preparing and submitting regulatory dossiers for ROW markets, specifically LATAM, MENA, and CIS regions. The ideal candidate possesses comprehensive, current knowledge of international regulatory guidelines and requirements. Responsibilities include identifying relevant guidance documents and standards, providing interpretative support to cross-functional teams throughout product development and manufacturing, and managing the lifecycle for products filed in these markets. You will review technical documentation from development and production for dossier completeness. The role demands the ability to work effectively under pressure in a high-stakes business environment, collaborating well with various departments to meet strict submission deadlines.
Naprod Life Sciences Pvt. Ltd · MH, IN