Assistant Manager- Plant Regulatory Affairs

3 days ago

Pithampur Indore, India Gufic Group Full time

Job Description

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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