Regulatory Project Coordinator Supporting Trainee

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

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

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?

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!