Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with a...
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 bot...