Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Budapest
- Employment
- Part-time
- Experience
- BSc or MSc university studies in Life Sciences (active student status for minimum 12 months) in Hungary 25 -hour availability/week
- Education
- BSc or MSc university studies in Life Sciences (active student status for minimum 12 months) in Hungary
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Role Summary
Supports the start and follow-up of regulatory submissions for Sanofi products, including EU and US submissions. Coordinates regulatory administration and information management, maintains repositories, contributes to process and document improvements, and supports KPI monitoring and reporting.
What You'll Do
- Deliver the start and follow-up of submissions, including initial and health authority requests for supplementary information, according...
- Coordinate administrative and regulatory activities in Veeva Vault RIM, and monitor and follow up the team's KPI dashboard and tracking...
- Support simplification of end-to-end processes and retrieve information from regulatory databases and regional regulations.
- Maintain and improve current regulatory repositories.
- Participate in preparing and updating quality documents, processes, tool enhancements, and training materials related to the role.
- Run reports, collate data, and report KPIs according to oversight and governance processes.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
BSc or MSc university studies in Life Sciences in Hungary, with active student status for at least 12 months and availability for 25 hours per week. Strong written and verbal English communication, attention to detail, organizational skills, and ability to collaborate in cross-functional, multicultural, matrixed environments. Interest in EU and US regulatory affairs, willingness to learn electronic systems and regulatory databases, and curiosity about regulatory dossiers and eCTD format.
Preferred
- Basic academic exposure to regulatory frameworks is a plus.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
- 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
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!
About the company
Sanofi
Large Enterprise
Sanofi is a global healthcare leader committed to promoting health and well-being through the development of innovative medicines, vaccines, and therapeutic solutions. With a diverse portfolio that spans multiple therapeutic areas, including diabetes, oncology, and immunology, Sanofi is dedicated to addressing pressing health challenges and improving patient outcomes worldwide. Headquartered in France, the company employs over 100,000 individuals across more than 100 countries, fostering a culture of collaboration and scientific excellence to drive advancements in healthcare.