Manager - 2

Review and compile data for product registrations, prepare responses to deficiency letters, and maintain life-cycle changes for drug product registration dossiers.

Requirements

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities.
• 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