Provided Regulatory support for BRAZIL operations.Filings with minimum lead time in ANVISA after grid finalization.Product development support.Training to inter departments.Query response & secure approval.Product launch support.Variation& Life cycle management.Regulatory support for other LATAM & EM markets.Worked on differentiated products & lyophilized products & ophthalmic & got approvals too with minimization of queries.To help analytical team to prepare validation protocols as per RDC 899& 166.Solving validation queries.Imparting training to R& d & plant on analytical Validation & post approval guidance.Part of CMC team for global filing projects.Clearance of backlog projects as per ANVISA calendar.

 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

Dossier compliance with respect to country requirement & submission for regions- RUSSIA, CIS, AFRICA, APAC as per their format and Latest CTD format.Reviewing various technial documents including the Development reports, API specs, RM specs, Product specs, Stability protocols, Stability data.Labelling and packaging in co-ordination with Packaging department.Planning, Reviewing and supervising the filing of applications for product registrations for export.Ensure the regulatory submissions are adequate and error free, with minimum open issues.Monitoring of export orders in accordance to registration.Co-ordination with F& D, Analytical development lab, production for various document filings and provide them regulatory insight.Attending meetings with General Manager, Plant Head, COO, all department mangers for planning and supervising filing of applications.