
This remote Director-level role focuses on regulatory CMC strategies for drug-device combination products, specifically autoinjectors and inhalation systems. The position involves leading technical content development for global submissions, conducting critical scientific assessments to ensure regulatory compliance, and collaborating with cross-functional teams to support product development and lifecycle management. The role offers the opportunity to drive innovation in complex medical delivery systems within a collaborative environment that values diverse perspectives and scientific curiosity. Key responsibilities include managing IND, NDA, and post-approval documentation while maintaining strict adherence to global health authority guidelines. The position supports a mission to deliver life-changing medicines worldwide with minimal travel requirements.























