<ul><li>Preparing, reviewing and submitting product dossiers as per CTD (Common Technical Documents), ACTD, ROW countries as per guidelines.</li><li>Preparing, reviewing and submitting renewal documents/renewal dossiers/ variations/responding to queries raised by Ministry of Health, International agencies as well as the various customers.</li><li>Involved in co-ordination with Plant, R&amp;D and QA-QC Department for preparation and receiving &amp; reviewing of technical Documents such as DMF, Stability data, etc. and also arranging for the samples required for submission along with the product dossiers.</li><li>Checking of printed packing materials</li><li>Tender submissions.</li></ul>

Regulatory Affair