Regulatory Affairs professional. Key skills; Transition, team and resource management , process optimization.Successfully built and leading the international team for Asia and pacific ; Rest of Africa, South Africa & Latam submissions, variations and resolutions.Providing strategy for CTD conversion, CTD submission and Variation filingPresently involved in managing the entire project , coordination with client ,meeting client expectation, project tracking , preparing charter .Managing and ensuring timely deliverable from the team in India, Asia Pacific, Latam , South Africa and Rest of Africa.Overall responsible for regulatory operation.Specialties: CTD , ACTD, GCC filing, TGA filing Team managementStrategic planning for upcoming projectDesigned process flow and RA SOP’sInternal Training.Regulatory support to relevant departments.Timeous and efficient processing of Regulatory submissions.New Product Applications & maintenance of product life cycleMaintenance on dossiers MRF/ CTD Updates for extensive range of marketed products.Due diligence on prospective dossiers.Amendments and transfer of applicancy projectName Change projectEnd to end training on new projects.