Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Senior Associate, Regulatory Operations is responsible for various day-to-day functions related to document publishing, submission compilation, regulatory information management, and submission management among other tasks as required. Under the direction of the Senior Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs, MAA and related amendments/supplements in eCTD format. The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.