Regulatory Project Coordinator Supporting Trainee
Employer · Sanofi
Licensing officer
Administrative assistant
Legal specialistStudentsPart-timeBudapest, Váci Greens
Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide.
Tasks
- Deliver key start and follow-up of submissions, initial/HA Request for Supplementary Information as per plan/requests for Sanofi products including EU and US submissions
- Coordination of administrative and regulatory activities in Veeva Vault RIM system, monitor and follow-up the team's KPI dashboard, tracking systems
- Applying simplification of the end-to-end processes and retrieve information from regulatory database and regional regulations
- Maintenance and improvements of the current regulatory repositories already in place
- Participate to the preparation and update of quality document, processes, tool enhancement and training materials pertaining to role
- Monitor KPI's by running reports, collating data and report as per oversight and governance process