Manager - 1

2 days ago

India Sun Pharmaceutical Industries - Full time ₹ 5,00,000 - ₹ 15,00,000 per year

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

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