Regulatory Data Specialist

Regulatory Data Specialist

• Location: Budapest

• Flexible working: 60% office, 40% home

• Job type: Permanent, Full-time

About the job

The Regulatory Data Specialist is responsible for regulatory data management in collaboration with various customers, ensuring data is collected, verified against sources, and entered in regulatory systems according to processes, regulations, and timelines. Contributing to regulatory strategy and planning to ensure ongoing submissions and expected approval timelines are adhered. Enable proactive responses to compliance risks. Maintaining compliance and developing strategies for evolving standards are critical activities for protecting and supporting the Sanofi product portfolio.

Main Responsibilities

Data Management

• Collect, verify, and enter critical regulatory product data to meet Sanofi and SDS timelines with highest quality standards
• Manage complex regulatory product data on behalf of regulatory data owners
• Ensure data quality and compliance monitoring of structured data standards (IDMP, xEVMPD, FMD)
• Reference SmPCs and regulatory documentation in Vault RIM for Dossier Management

Health Authority & Submissions

• Lead responses to structured data inquiries (xEVMPD, IDMP) from health authorities
• Collaborate with stakeholders and vendors to resolve data inconsistencies and ensure timely submissions

Process Improvement & Support

• Contribute to system and process improvements for evolving regulatory requirements
• Participate in User Acceptance Testing, training delivery, and documentation
• Support User Support functions (User Access Management, Translation System Coordination, Records & Document Management)

Cross-Functional Collaboration

• Maintain close alignment with Data Management and Data, Digital & AI teams
• Drive operational effectiveness within GRO organization

About you

• Excellent knowledge of the pharmaceutical industry and related processes.
• Strong communication, negotiation and influencing skills. He/she will be at ease working in a matrix environment and display the necessary multicultural sensitivity in such a Global environment.
• Ability to lead complex projects and timelines in a matrix team environment.
• Strong attention to detail and accuracy and be a role model for the team.
• Ability to work in an agile way, willingness to learn, adapting quickly to new circumstances, and changing timelines.
• Big picture thinking: Having a sound understanding of the regulatory processes to be able to judge what is possible to be delivered and in which timelines.
• Dedicated and persuasive “can-do” attitude and entrepreneurial spirit.
• Established ability to problem solve user issues.  Demonstrated critical thinking.
• Very good affinity to digital evolution, understanding of the relationship between systems and electronic databases.
• Collaborative team player with orientation towards building and maintaining effective relationships, collaboration skills and strong culture awareness.

Qualifications

• Bachelor’s degree in sciences, healthcare, engineering or regulatory affairs or equivalent.
• 3+ years of experience in the pharmaceutical industry with direct regulatory affairs experience.
• Ability to work across cultures.
• Excellent written and verbal communication skills in English.
• Experience with information management tools preferred.
• Experience with internal or external customer support/service a plus
• Experience/knowledge in managing regulatory Product data/databases and Document Management systems (e.g., VAULT RIM) is a plus.

Why choose us?

• Explore More — Shape a career as unique as you, with the support to build future-ready skills and explore new paths across the business.
• Chase Change — Be empowered with AI-powered tools and encouraged to be bold, helping shape the future of science and healthcare.
• Do Right — Know that your work drives meaningful impact — for patients, communities, and the planet.
• Make Miracles — Bring the miracles of science to life, as part of a team united by shared purpose.

Office of the Year 2025 – Evolution Award
Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.

Marketing Diamond Award 2026 – Employer Branding
One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.

BSC Investor of the Year 2025
Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector.

PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers
Ranked 3rd among the most attractive employers in Hungary.

Hungarian Employer Branding Awards 2025 – Gold & Silver
Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver).

Pursue progress. Discover extraordinary.

Join Sanofi and step into a new era of science—where your progress can be as transformative as our work. We believe in you, support you, and give you the opportunity to go further, think faster, and achieve what you once thought impossible. With us, you can shape the future—ask questions, explore new paths, and find solutions that truly reach those who need them most. Ready to use the power of science to improve people's lives? Let's pursue progress together and discover the extraordinary!

At Sanofi, we provide equal opportunities for everyone regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, veteran status, or any other legally protected characteristic.

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.

#Sanofi #WeNeverSettle #PursueProgress #DiscoverExtraordinary #SanofiCareers #joinSanofi #jobopportunities #careeropportunities #Sanofi_Budapest_Hub #Budapest #LI-Hybrid #LI-EUR

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!

The salary range for this position is :

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.