Regulatory Affairs Director — FDA Submissions & Strategy

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including generics across multiple dosage forms. This remote-eligible role favors candidates in the Minneapolis–St. Paul area.

You will lead cross-functional teams, coordinate FDA interactions, and ensure compliant development and launch activities throughout preclinical, clinical, and manufacturing stages.