Responsibilities: Works under general direction to guide design and development of advanced biomedical solutions that are needed to meet key business objectives relating to the e…
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, …
Responsibilities: Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products. Technical leader of the design…
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authori…