About this role
Principal Tasks & Responsibilities
New & Renewal Dossier Filings: Prepares, reviews, and submits new 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