Remote Regulatory Affairs Director: ANDA & FDA Strategy

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including ANDAs across various dosage forms.

The role requires leading cross-functional teams, guiding development programs, and interfacing with the FDA to ensure compliant filings. The position emphasizes strategic regulatory leadership, risk mitigation, and timely communications with regulatory agencies to support successful market entry