Job title: Ancillary Document Coordinator

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?

Join our global regulatory affairs team as an Ancillary Document Coordinator and you’ll help us request all ancillary document types intended to be submitted for the GRA portfolio, from standard to complex. You’ll be responsible for the operational ancillary document planning request, ability to prioritize workload, and negotiate timelines with key stakeholders.  You’ll also partner closely with Vendors to execute the preparation and / or request of the ancillary Documents according to the planning.

Main responsibilities:

• Manage end‑to‑end ancillary document requests by applying strong project management skills and expert regulatory knowledge, including country‑specific requirements
• Act as a subject‑matter expert, advising cross‑functional stakeholders on ancillary document regulations, guidance, and submission requirements to ensure shared understanding and compliance
• Create, maintain, and continuously improve standardized ancillary document templates to support high‑quality, timely submissions aligned with Sanofi and Health Authority standards
• Draft, review, and submit CPPs; interact directly with French Health Authorities to request CPPs and GMP certificates as required
• Coordinate with external vendors and internal stakeholders to manage ancillary document requests, tracking, shipment, and associated tools
• Manage the upload, lifecycle, and maintenance of ancillary documents in Vault RIM, including completion of accurate and compliant metadata
• Ensure compliance with applicable Health Authority requirements, including document content, formats, and local legal regulations
• Monitor regulatory intelligence, evolving requirements, and industry best practices related to ancillary documents and ensure timely integration into processes
• Drive continuous improvement initiatives, identifying opportunities to streamline workflows, improve quality, enhance efficiency, and reduce errors through process optimization and digital innovation

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

Soft Skills:

• Self-starter, who is motivated
• Ability to work across cultures
• 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 to troubleshoot issues and find solutions related to ancillary document challenges

Technical Skills:

• Proficiency working in MS Office Suite
• Experience in document management environments/systems, and/or RIM systems is advantageous

Education:

• Minimum Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience

Language(s):

• Strong French and English skills (min. B2, verbal and written), ability to exchange fluently in a global environment

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.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#R&D

#LI-EUR #LI-hybrid