With an exciting company that is at the forefront of cancer immunotherpay
US lead in providing both strategic input and day to day guidance for the projects assigned.
Responsibilities (include but are not limited to):
- Provide regulatory guidance to cross-functional teams ensuring the project assigned progresses from IND stage to launch within company agreed timelines.
- Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
- Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes
- Ensure submission-readiness of all regulatory documents related to the project
- Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.
- Bachelor's degree and 5 years of relevant US regulatory (FDA) / drug development experience
- Experience with INDs, NDAs, BLAs
- Good communication skills - both oral and written
- Preferred: oncology experience and MA/MS, PHD, pharmD
- Organizational skills - detail oriented and can deal with frequent changes in product activity
- Strong knowledge of eCTD elements and structure
Sthree US is acting as an Employment Agency in relation to this vacancy.