Executive- API RA

About the role

This role focuses on strategic filing (DMF/CEP), maintaining the complete lifecycle of submissions through quality documentation, timely approvals and business continuity.

What you'll do

• Pre-approval - Prefilling Support and New DMF / CEP Fillings: Review of the various Pre-filling documents [TTD / Process / Specifications / Validations / Stability ext.]…
• Meeting submission timelines of assigned projects for identified markets
• Pre-approval - Deficiency Responses: Review comments of the various response documents with agreed timelines with stakeholders. Meeting submission timelines of assigned…
• Change control, Vendor Notifications and Deviations: Review of change controls, deviations, vendor notifications and their impact assessment on the submissions
• Post Approval - DMF / CEP Amendments [Post approval changes / variations]

What you need

• 4–7 yrs of experience
• Regulatory affairs
• Negotiation
• GMP
• Chemistry
• Documentation
• M.Sc