<ul><li>Preparation of dossier for US &amp; Europe.</li><li>Coordination with cross function team and review of technical document.</li><li>Preparation of deficiency responses.</li><li>Publishing submission in e-CTD application.</li><li>Query response</li><li>Preparation of module/ Administrative documents.</li><li>Having good in written and oral communication skill are desired.</li><li>Life cycle Management of product which includes CCF evaluation, variation preparation and filling.</li></ul>

Executive Regulatory Affairs