Manager / Sr. Manager - Regulatory Affairs

2 weeks ago

Mumbai, Maharashtra, India Gufic Group Full time ₹ 5,00,000 - ₹ 10,00,000 per year

Responsibility

  • Compilation and review of dossier for DCGI submission on Sugam portal
  • Aware of regulatory requirements and guidances for dossier submission to DCGI
  • Must have experience for Biological, FDC and another new drug or subsequent new drug submission
  • Follow-up with DCGI for submission and approval
  • Active participation in all DCGI inspections
  • Aware about all the requirements of CT-04, CT-10 application
  • Responsible for Query response and on time approval of product
  • Submission of SAE updates to DCGI portal and further follow-up
  • Communicate with all Cross functional team for required documents and support
  • Responsible for submission of Dual use NOC and its approval on priority
  • Maintain all contacts with state as well as DCGI office for routine updates about application
  • Ready to travel manufacturing site as well as DCGI offices
  • Responsible for maintenance of all database and submit weekly progress report to management about each application
  • Follow up with CDSCO regional offices whenever required for query related to inspections and other plant related support
  • On time submission of IBSC portal and approval
  • Maintain track record of IBSC meeting and submit minutes to portal
  • Good communication skills and drafting of dossier
  • Well aware about Microsoft (Word, Excel and Power point) skills

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