
This remote Director-level role focuses on regulatory CMC activities for drug-device combination products, specifically autoinjectors and inhalation systems. The position involves leading regulatory strategies, reviewing technical content for global submissions such as NDAs and INDs, and ensuring compliance with international health authority requirements. Key responsibilities include assessing scientific data for critical risks, coordinating with cross-functional product teams, and managing post-approval variations. The role appeals to experienced professionals seeking to drive innovation in combination product development within a collaborative environment that values diverse perspectives and continuous learning. The position offers full remote flexibility with minimal travel requirements.
















