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 FDA in eCTD format.
Preparation, Review and filing of all post marketing activities which include, timely submission of Annual Reports, CPP, release of detained products at customs etc.
Respond to deficiencies related to Chemistry, Bioequivalence and Patent in a timely manner.
Review and approve Prototype formulation during early drug development stages to be compliant with Inactive Ingredient Database and FDA guideline.
Review and submit...