Regulatory Affairs

Position Title : Executive Regulatory Affairs
Department : Regulatory Affairs
Years of experience required : 1 to 4 yrs Only Pharma Graduate

Job Details :

  • Preparation of dossiers (CTD, ACTD, NEES, Country specific format) including process validation, Product Development report, and Stability data.
  • Must have handled ROW market and CIS countries.
  • Compilation of documents for eCTD dossier as per EU guidelines.
  • Co-ordination and Collection of Dossier data and samples from plant.
  • Co-ordination with plant for audit and for specific plant registration.
  • Application of COPP and FSC in plant (P2P and LL) and its follow up.
  • Commercial product artwork and MPD checking.
  • Query solving after submission of products.
  • Compilation and preparation of Tender documents/dossier.
  • Co-ordination for outsourcing of DMF/Clinical study.
  • Follow up from client for submission and registration.
  • Checking of Master Manufacturing Documents for different products.
  • Preparation of draft for artwork and leaflet.

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