Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet company KPO Preparation, Review, and filings of new ANDA, NDA, IND and DMF for the U.S. FDA in eCTD format. Preparation, Review…