Skills:
Good understanding of Investigation New Drug Application (IND), IND amendments (21CFR 312), NDA (21CFR 314), CTD submission for NDA both paper and electronically, ANDA, DMF, 510(k) submission, PMA for marketing approval of drugs, medical devices. FDA consulting meetings, post marketing surveillance (Phase IV). Comprehensive knowledge of MS Word, MS PowerPoint, MS Excel. Ability to perform tasks cooperatively in a team environment as well as independently.