Job title: EU Platform Regulatory Trainee

Location: Budapest- Sanofi Budapest HUB, Váci Greens

Flexible working: 60% office, 40 % home

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:

Maintenance / digital regulatory activities:

• Deliver key start and follow-up of submissions, Initial/HA Request for Supplementary Information as per plan/requests for Sanofi products including European procedures (Worksharing, MRP/DCPs & CPs) and for deferred action countries following the approval of EU reference countries
• Applying corresponding operational model set up by Partner Market EU (PME) team or Swiss affiliate & follow the corresponding Ways of Working and training materials associated

Administrative & digital regulatory activities:

• Including coordination of administrative and regulatory activities related to administrative changes, Marketing Authorization Transfer (MAT), Orphan Drug Designation (ODD), Pediatric Investigational Plan (PIP) and RPI (Research Product Identification) transfers

Non-core regulatory activities:

• Applying simplification of the end-to-end processes leading to limit contribution of RS and affiliates 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:

• Ongoing university studies in BSc or MSc (active student status) in the field of Life Sciences
• Min. 30-hour availability/week

Soft and technical skills:

• Strong interest in EU 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)
• Interest in change management practices and the digital transformation of regulatory processes (e.g., EMA digital initiatives)
• 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

When joining our team, you will experience:

• Bring the miracles of science to life alongside a supportive, future-focused team.
• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• Flexible home office policy
• You'll face challenging tasks with professional responsibilities
• Trainee training program opportunity
• Internship and thesis support
• Paid leave for trainees
• Join a great community & special event (Weekly Yoga/Pilates classes, Monthly Board Game Nights, Summer/Winter Events, Well-Being Lectures & Sport Clubs)

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, gender identity or Veteran status.

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

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.