To plan, prepare and review of high quality dossier with support and guidance, assuring technical congruency and regulatory compliance, meeting agreed upon timeline.Review guideline for first time dossier preparation. Lead a team (NMT 5) of regulatory. GAP Analysis for current products Professionals. Query Responses, Launch of the product & life cycle management for global Regulatory.

To plan, prepare and review of high quality dossier with support and guidance, assuring technical congruency and regulatory compliance, meeting agreed upon timeline. Including review & approval of doccuments related to domestic / India along with artwork. Having exposure of Product permission, COPP, Loan License, CDSCO related activity, approval of site lay out, FDA, CDSCO Related activity along with SUGAM, ONDLS Portal

📌 Regulatory Affairs Executive (Valthera)
🏢 Concord
📍 Valthera