Sr Ctry Approval Spec

**Work Schedule**



Standard (Mon-Fri)



**Environmental Conditions**



Office



**Job Description**



- Prepares, reviews and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy.



- Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines.



- Ensures the submission process for sites and studies are aligned to the critical path for site activation. - Maintains contact with investigators for submission related activities;



- Serves as key-contact at country level for either Ethical or Regulatory submission-related activities.



- Ensures the local country study files and filing processes are prepared, set up and m...