Compiler

Requirements: 5-7 Years of core regulatory experience for Finished Product from reputed Pharma company with sound knowledge of New Product Submissions, Deficiency Response, Post Approval Variations & Lifecycle Management. Prior experience of handling of Middle East region (Saudi Arabia, UAE, Oman, Jordan, Qatar etc.) will be an added advantage. Key Job Role: Compilation and review of new registration dossiers in CTD or eCTD format as per country requirements. Review of Technical Documents (ODMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) for the submissions. Compilation and review of deficiency responses. Preparation and submission of variation packages for post approval changes. Communication and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. Review of artworks & comments for ongoing commercial supply & products for the new launch. Preparation and maintenance of various registration Data base & updating at Central Depository Compilation and Review of commercial documents for annual updates to the agencies. Co-ordinate with supplier through dedicated sourcing team to get DMF, GMP certificate etc. for regulatory actions.