Providing the support to regulatory affairs team at Pharmazone as Senior Executive.
Timelines management and delivery of the project.
Looking after Documentation of the regulatory affairs department.
Technical review of documents of products received from client for registration purpose.
Undergoing Gap analysis of documents/data required for dossier preparation.
Drafting and review of dossier for drug substance, drug product and administrative sections
To update regulatory guidelines knowledge database regularly.
Work together with cross-functional teams to ensure regulatory requirements are met throughout the dossier submission and product lifecycle management
Prepare & review the responses for deficiency letters received from health authorities during the evaluation of marketing authorization/drug registration procedures.
Perform regulatory submission procedures for US (ANDA), Europe, and other ROW markets.

📌 Walk In Regulatory Affairs Executive Ahmedabad
🏢 Pharmazone
📍 Ahmedabad