Title:  Manager - 1

Job Description:

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities like – US-FDA, Health 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
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA
• Reviewing of the plant change control and established the variation strategy  for submission
• Review of query response prepared and compiled by regulatory associates
• Review of all the documents received from stake holder for  dossier compilation , Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities