The Regulatory Affairs Director CMC acts as single contact point for CMC regulatory strategy for critical submissions: INDs, NDAs, MAAs as well as Investigational Medicinal Products (IMPs) The successful candidate will oversee all CMC regulatory...
Amicus Therapeutics, Inc.
SUMMARY OF POSITION
The Director, CMC Regulatory Affairs will provide regulatory leadership and oversight to the Amicus Therapeutics cross-functional teams in both pre- and post-approval roles. Emphasis will be primarily on the biologics product...
We are a publicly traded (NASDAQ: INSM) biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for...