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Manager / Sr. Manager - Regulatory Affairs
2 weeks ago
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
