Assistant Manager- Plant Regulatory Affairs

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

Skills Required

Qms, regulatory audits , Plant, Power Point, Ms Word