As part of a Regulatory team, manage clinical and nonclinical aspects for the priority development project in the company, an enzyme replacement therapy for a lysosomal storage disorder. Create timelines and track deliverables to timelines to ensure that all submissions are submitted on-time. Develop and/or review regulatory documents to ensure that all submissions are submitted with quality. Actively participate in internal interdisciplinary teams by providing Regulatory advice as needed. Proa...
