Description
Padagis US LLC is hiring a Director or Associate Director of Regulatory Affairs to lead regulatory strategy, FDA submissions, approvals, and compliance for generic pharmaceutical products in the United States. The role oversees ANDA, IND, NDA, and amendment submissions; coordinates with FDA and cross-functional teams; manages regulatory risks; supports product development and market entry; and mentors junior regulatory staff. It is a remote position for candidates residing in the United States, with preference for candidates in the Minneapolis-St. Paul, Minnesota area.
