Manager - 2

Executive and Sr. Executive

• Review all data and documents related to product registrations for various health authorities.

• Compile registration dossiers for submission to various health authorities like – China , Canada, Europe, Australia/New Zealand, Japan and Israel.

• Prepare responses to deficiency letters received from various agencies.

• Maintain life-cycle / post approval changes for drug product registration dossiers.

• Provide regulatory support to cross functional departments.

• Prepare and submit scientific advice to various health authorities.

• eCTD compilation, verification and submission through electronic gateway