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