Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs... changes. Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal...
and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet..., submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER...