• Location: Budapest, Hungary

• Job type: Permanent, full-time

• Hybrid working

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.

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?

Role Overview: the EU Platform Regulatory Coordinator is responsible for providing submission excellence support for lifecycle management (LCM) activities for all EU regulatory procedures, including Centralized Procedures (CP), Mutual Recognition Procedures (MRP), Decentralized Procedures (DCP), and Worksharing initiatives, while providing additional operational support to other Key Markets countries (Switzerland, Israel).

Main responsibilities:

Regulatory Operations Coordination:

• Coordinate all centralized EU regulatory operational non-core LCM activities across the Sanofi portfolio
• Serve as the primary excellence partner and contact point for GBU Regulatory Strategists, EU regulatory affiliates and key regulatory stakeholders including CMC and labelling strategists
• Manage and coordinate labelling variations, initial variations, and responses to requests for supplementary information
• Oversee established centralized EU activities (e.g., Article 23 procedures)

Process Excellence & Knowledge Management

• Maintain and enhance current regulatory repositories and ensure training materials and Ways of Working (WoWs) remain current with evolving internal processes and updated EU regulations
• Drive continuous improvement of end-to-end (E2E) processes through proactive, solution-focused approaches
• Champion new initiatives for automation, digitalization and process simplification

Digital Transformation Leadership

• Act as key digital partner supporting business operations for all digitalized activities aligned with the EMA Digital Roadmap
• Lead implementation and optimization of EMA digital capabilities to manage the authorisation and lifecycle of medicines including all activities related to EMA portals: PLM (eAF/ePI), ESMP and IRIS.
• Develop and implement processes and reports to centralize and automate EU regulatory activities, including notification of marketing status and PLM functionalities

About you:

Experience:

• Minimum of 3-4 years in pharmaceutical industry
• Demonstrated experiences in European Regulatory Affairs

Soft and technical skills:

• Regulatory & Compliance Knowledge: good understanding of post-authorization regulatory activities and knowledge of GxP (Good Practice) principles and quality management systems
• Data Management & Reporting: proficiency with regulatory databases and document management systems and ability to generate regulatory reports and track submission metrics
• Analytical with a problem-solving capability with a forward-thinking approach to digital transformation in the evolving EU regulatory landscape
• Strong coordination skills and good planning, project and people management abilities
• Ability to work effectively with multifunctional and multicultural teams
• Able to multi-task and perform well under pressure
• Understanding of organizational and intercultural sensitivities and able to apply this knowledge to day-to-day practices
• Strong networking ability with digital experiences
• Communication and negociation skills

Education: Technician, Physician, Pharmacist, Veterinarian or Life Sciences Degree

Languages: Fluent spoken and written English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2025" award winner with flexible home office policy

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

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).

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover Extraordinary together.

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

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.

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#Sanofi_Budapest_Hub #Budapest

#R&D #RegulatoryAffairs #RegulatoryManager #Regulatorycoordinator

#LI-EUR #LI-hybrid

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.