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 recent 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
Valuable communication skills and drafting of dossier
Well aware about Microsoft (Word, Excel and Power point) skills