Regulatory Project Coordinator Supporting Trainee
Employer · Sanofi Group
Licensing officer
Administrative assistantOffice clerkPart-timeStudentsBudapest District XIII, 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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives.
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
Requirements
- BSc or MSc university studies in Life Sciences (active student status for minimum 12 months) in Hungary
- 25 -hour availability/week
- Strong interest in EU and US regulatory affairs, any basic academic exposure to regulatory frameworks is a plus
- Willingness to learn how electronic systems and regulatory databases are used in pharmaceutical environments
- Curiosity about regulatory dossiers and their structure (e.g., eCTD format)
- Attention to detail and ability to support tracking of regulatory activities in internal systems
- Openness to working in a cross-functional and multicultural team setting
- Strong organizational skills and eagerness to support activities requiring planning and coordination
- Ability to collaborate in a highly matrixed, fast-paced environment
- Strong written and verbal communication skills in English