Regulatory Project Coordinator Supporting Trainee

Location: Budapest – Sanofi Budapest HUB, Váci Greens  

About the job  

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. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? 

Main responsibilities:  

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

About you   

Experience :  

BSc or MSc university studies in Life Sciences (active student status for minimum 12 months) in Hungary

25 -hour availability/week 

  Soft and technical skills :  

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

  Languages : Strong written and verbal communication skills in English