Job title: Regulatory Renewal Coordinator (Maternity Cover)

Location: Budapest, Hungary

Job type: Maternity cover, fixed-term (with end date of  2028. 09. 30. )

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?

Join us as Regulatory Renewal Coordinator and you will have the primary accountability for the Reference Renewal Plan preparation and maintenance. You will ensure submission or dispatch of Renewal dossiers of high quality and according to timeliness defined in the Renewal Reference Plan.

This role is responsible to ensure implementation of E2E Renewal process improvements and development/update of the appropriate digital tools aligned with GRA Global strategy.

Main responsibilities:

• Coordinate and ensure timely preparation and submission of renewal dossiers to Health Authorities in collaboration with Affiliates, Distributors, Regions, and GRA Operations
• Maintain and update the Renewal Reference Plan (RRP) for products within scope
• Drive process simplification and harmonization, proposing improvements to the Renewal Process Owner
• Act as Subject Matter Expert (SME) for renewal activities, supporting internal and external stakeholders
• Contribute to renewal-related initiatives, tools, and continuous improvement efforts
• Collaborate with stakeholders to monitor regulatory requirements and define appropriate renewal strategies
• Support development and maintenance of renewal tools, reports, and quality documents
• Track KPIs for renewal submissions and provide input to performance dashboards

About you:

Experience:

• Relevant professional experience in Pharmaceutical Industry;  direct experience in Regulatory Operations and/or Regulatory Affairs preferred
• Familiarity with regulatory guidelines, standards, and requirements relevant to ancillary document management and submissions in the pharmaceutical industry
• Understanding of regulatory processes and documentation requirements for regulatory submissions
• Independent abilities to learn quickly and adapt to new technologies/environment
• Experience working in a matrix, international, and cross-functional environment

Soft Skills:

• Self-starter, who is motivated
• Solid coordination and project management skills, with the ability to drive high-quality, on-time deliverables
• Ability to identify and communicate opportunities for process improvement
• Strong attention to detail and accuracy
• Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization
• Strong problem-solving skills, with the ability to analyze complex issues and propose practical solutions

Technical Skills:

• Proficiency in MS Office (Word, Excel, PowerPoint), Adobe Acrobat, and collaboration tools (e.g., SharePoint, Teams)
• Experience in document management environments/systems, and/or RIM systems is advantageous

Education:

• Minimum Bachelor’s degree, or equivalent, in Regulatory Affairs, the life sciences, or related areas of study, and relevant experience

Language(s):

• Fluent in English, with strong written and verbal communication skills

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

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Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.