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Regulatory Affairs

Regulatory Affairs

ConfidentialMumbai
30+ days ago
Job description
  • preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission
  • Preparation of respective CTD sections and submission of final query response to agency
  • Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval
  • To upload documents in national portal for respective European regulatory agency
  • Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation
  • Review of the mockups for all regulatory submissions and commercial supplies
  • Maintenance of internal database
  • Co-ordination with consultant for national submissions, product information translation, readability testing etc
  • Review and approval of change control and deviations
  • Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations and renewals
  • Review of variation packages

    • Skills Required

    regulatory documentation, Compliance Management, Regulatory Submissions

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    Regulatory • Mumbai

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