Principal Tasks & Responsibilities New & Renewal Dossier Filings: Prepares, reviews, and submits current and renewal registration dossiers to support SBU targets across specified countries.

MoH & Customer Query Resolution: Drafts and shares pre-registration responses to customer and Ministry of Health (MoH) queries within stipulated timelines.

Technical Document Review: Approves critical regulatory documents including Change Controls, specifications, stability protocols, MMD II, and artwork for compliance. Post-Approval Life Cycle Management: Updates dossiers and files variations for post-approval changes to maintain ongoing market compliance.

SAP Order Approval: Reviews and approves SAP orders for specified international markets across all customer accounts. Cross-Functional Coordination: Partners with R&D;, QA, QC, Marketing, and Purchase to streamline filing timelines,



tender submissions, and query responses.

Database & Project Tracking: Maintains registration databases and updates project trackers for approved products, ongoing filings, and active queries.

Team Guidance & Compliance: Educates team members on changing registration guidelines, project updates, and unplanned SBU priorities..

Key Skills & Competencies Functional / Technical: Preparation, review and submission of new as well as renewal dossiers Response to customer and respective MoH queries Maintain appropriate database for registration Behavioural: Result Orientation – Level 4 Process Orientation – Level 4 Team Work & Collaboration – Level 4

📌 Deputy Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka