Sr.Executive- International Regulatory Affairs
Vadodara Area, India
Provided regulatory support for LATAM (Brazil, Mexico) operations of the organization. Ensure project initiation after Grid finalization & PE/DP study till completion of PE study & on completion of BE study, timely dossier filing to meet project timelines for Brazil market. Compilation and review of registration dossiers in line with expectation of country regulatory authorities & required formats (CTD,Country specific), ensuring submission with minimum lead time. Dossier preparation for EU-DCP filing and Australia marker( Module 2,3) Preparing dossiers for Online review/audit by customers and handling respective queries. Coordination with other departments (Formulation, Analytical, Project Management, Quality, Plant, CRO, Packaging) Responding with justification to technical queries/ additional information’s as required by different regulatory authorities & Customers. Dealing with International Business Team, Project Management Team and attending telecons on regular basis with different clients for updating status & progress of projects. Dealing with API Team members to get details for CEP, LOA, 3.2.S and Quality Overall Summary for API Part. Review & authorisation of Change Control & provide reporting category. Knowledge of DMS – Document Management System for various documents like BMR’s, BPR’s, Specifications and STP’s. Keep track of timelines for activities at ADL, F&D, and Plant Site QA and QC. Worked on formats: CTD, ZA-CTD, ACTD, e-CTD. Knowledge about working on software like Pharma-Ready,EURS Validator. Continents worked: LATAM EU, Australia South Africa Africa Handling Alembic' & customers filings like Sanofi,Sandoz, Actavis, Adcock Ingram,Teva, Teuto, Amgen, Merck, Glenmark
