Assistant Manager- Plant Regulatory Affairs

2 weeks ago


Pithampur, Madhya Pradesh, India Gufic Group Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities :

  • Review of CMC documents as per submission checklist
  • Aware of regulatory requirements and guidances for dossier submission
  • Review of all plant related change control and provide assessment
  • Support plant team for all regulatory audit
  • Maintain status of all submissions and approvals required for site QMS
  • Communicate with all Cross functional team for required documents and support
  • Communicate with customer regulatory team for document submission and change control approval.
  • Conduct weekly plant-RA team meetings for understanding document status
  • Support technology transfer team for new products
  • Co-Ordinate with F&D-Indore team for compilation of development related dossier documents.
  • Decide priority of document submission as per instructions from Management.
  • Respond all queries of customer on time
  • Responsible for on time submission of document to customer
  • Evaluate all post-approval changes and prepare variation package and share with client
  • Good communication skills and drafting of dossier
  • Well aware about Microsoft (Word, Excel and Power point) skills


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