Job Details

We are seeking a temporary Regulatory Affairs Operations Senior Specialist to join our team, ensuring Sangamo meets US and EU regulatory submission requirements. The successful candidate will be responsible for coordination, preparation, tracking and filing of document packages for regulatory submission from all areas of research and development. This is a temporary position. ESSENTIAL FUNCTIONS: Preparation, coordination, compilation, formatting, and filing of global regulatory submissions, including IN - Ds, CT - As, BL - As, Drug Master Files, DSU - Rs, Meeting Materials and IND amendments providing for changes in the clinical program and manufacture of the product. Understand electronic common technical document (e. CTD) submission requirements in both the US and EU and interface closely with publishing vendor(s) to process, validate and approve e. CTD submissions. Maintain/archive all regulatory submissions and correspondence for company sponsored projects, and all company related...Operations, Regulatory Affairs, Regulatory, Specialist, Senior, Operation, Technology