Regulatory Data and AI Specialist
Gentilly, FranceMarcy-l'Étoile, France Permanent Posted on May. 15, 2025 Closing on Aug. 15, 2025
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.
This job offer is accessible to all, regardless of gender.
Job title: Regulatory Data and AI Specialist
- Location: Gentilly
About the job
At Sanofi, we are transforming how Regulatory Affairs leverages data and AI to improve quality, speed, and compliance in delivering medicines to patients. As part of this journey, we are looking for a talented professional to join our team in Paris as a Regulatory Data and AI Specialist, acting as Capability Lead for the Global Regulatory Data Cloud (GRDC).
This permanent, full-time role is ideal for someone with an intense curiosity and the ability to connect conceptual data design to physical data flows. You will actively contribute to the evolution of Sanofi’s regulatory business data model, gaining a deep understanding of how data flows across systems, interfaces, and user needs.
In this role, you will collaborate with a vast network—beginning with the Decision Science & Analytics team and the Plai team—as well as MDM, Security, Interfaces, Integrity within and between systems, Data Operations, and Data Governance groups. You’ll ensure that the GRDC platform and associated data practices are trustworthy, scalable, and future-ready. You will also facilitate structured touchpoints with business stakeholders to continuously align the evolution of data capabilities with regulatory needs and strategic direction.
Main Responsibilities
GRDC Capability Leadership & Platform Evolution
- Serve as the Capability Lead for the Global Regulatory Data Cloud (GRDC), owning and maintaining the product roadmap, release planning and platform evolution, in alignment with strategic priorities and key partners
- Collaborate with data engineering, data science, and digital product teams to guide the prioritization, design and evolution of platform features
- Ensure proper integration with Veeva Vault RIM, leveraging the Direct Data API and applying knowledge of Vault’s data model and cascading it to the downstream GRDC subscribers
- Align GRDC with data quality, integrity, and compliance standards, working closely with quality leads
- Contribute to metadata strategy, tagging standards, and traceability models to ensure regulatory data is AI-ready and semantically rich
Data Model Ownership & Evolution
- Develop a robust understanding of Sanofi’s regulatory business data model, from conceptual through logical to physical layers
- Actively contribute to business data model evolution in collaboration with MDM and Data Governance
- Support enrichment, mapping, and simplifying regulatory data structures to meet evolving business and reporting needs
- Clarify object relationships, key identifiers, and cardinality to ensure consistent and compliant regulatory data models
Information Flow Optimization & Integration
- Design and optimize regulatory data flows from Authoritative Sources to Trusted Sources, including transformation logic and validation checkpoints
- Ensure secure and compliant data exchange through interfaces by collaborating with Security, Interface, and Data Operations teams
- Establish clear roles and responsibilities for data entry, transformation, ownership, and stewardship in alignment with GRA process architecture
Reference Models & Standards Alignment
- Ensure internal consistency and external alignment with DIA RIM Reference Model, IDMP Ontology, and internal initiatives like Data Genome and CARTER
- Assist in mapping existing data structures to reference standards and documenting cardinality between objects and fields
Stakeholder Engagement & Knowledge Sharing
- Act as a key point of contact and facilitate structured touchpoints with Regulatory Affairs, R&D, M&S, and Digital stakeholders to align data capabilities with evolving cross-functional needs
- Promote adoption and use of GRDC by enabling user-centric interactive tools; collaborate with internal communication and training leads to support change management and onboarding
- Maintain clear documentation (in SharePoint and other repositories) of data models, workflows, platform functionality, and decision logs
- Develop and maintain SOPs and training materials to support process transparency and knowledge transfer
- Support audit readiness and regulatory inspections by ensuring clear documentation and traceability
About you
Experience and education
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Data Engineering, or a related field
- Hands-on experience with Veeva Vault RIM, Direct Data API, and foundational data modeling principles
- Experience working in or with product/capability teams and contributing to quarterly OKRs or capability health metrics are a plus
- Proven experience with data visualization tools like Power BI and/or Tableau, as well as intermediate-level programming skill in SQL and Power Query
- Proven track record of project and/or product management that demonstrates strong understanding of both Agile and Waterfall product development methodologies
Soft and technical skills
- Comfortable collaborating with technical and non-technical teams, including data engineering, analytics, and business process leads
- Demonstrates systems thinking and intellectual curiosity—eager to connect the dots across data, technology, and regulatory processes
- Exposure to AI/ML concepts, NLP, or large language models (LLMs) is a plus
Languages
- Fluent in French and English
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#LI-FRA
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Pursue progress. 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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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