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