Job title:Senior Capability Analyst

• Location: Gentilly/FR -Marcy l'Etoile/FR

About the job

Our Team:

GRO Regulatory Data Digital & AI enables GRA to be a digital savvy and agile organization by fostering innovation, maximizing value, and driving simplification across process, data, and digital. As a key component of Sanofi's global regulatory strategy, we ensure that regulatory information is managed efficiently and effectively throughout the product lifecycle. The team are change agents that engage across GRA, partnering functions and external partners to enhance GRA's capabilities.

About Sanofi:

We’rean R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Key responsibilities include:

• Define and drive cross-domain capability roadmaps with enterprise impact
• Lead enterprise-level process architecture and governance, balancing standardization and innovation needs
• Design and orchestrate complex workshop programs and testing strategies to support solution development and validation
• Develop enterprise compliance strategies and risk mitigation approaches by maintaining accurate records and documentation
• Define requirements methodology and lead complex requirement initiatives
• Drive transformational process improvements with significant ROI across end-to-end regulatory capabilities
• Represent the organization during critical audits and regulatory inspections for the capability
• Work with Digital Product Owners, Business Process Owners, and SME design enterprise change management frameworks and governance
• Design enterprise change management frameworks and governance with the Training/Development and Communication teams
• Evaluate and champion strategic technology investments and trends in regulatory capability development, digital adoption, and AI in life sciences
•  Develop talent and lead workstreams
• Uphold Sanofi's Code of Ethics and integrity standards in all activities, ensuring compliance with global and local regulatory requirements and company policies

Team scope specific:

• Focuses on the end-to-end management of documents intended for submission, submission data, publishing activities, and content planning across the application lifecycle. This includes the orchestration of structured and unstructured content required for global regulatory submissions, ensuring consistency, traceability, and compliance. The team enables strategic capacity for content planning and execution of submission content, supporting timely and high-quality regulatory interactions
• Publishing activities encompass the preparation, validation, and dispatch of regulatory submissions to health authorities, ensuring alignment with regional requirements and technical standards. The team ensures that publishing processes are integrated with content and data management workflows, enabling efficient and compliant submission delivery
• Operating within the GxP-regulated environment for GRA Applications, the team acts as the Business System Owner (BSO) under the Agile framework. It ensures robust governance, alignment with regulatory requirements, and continuous improvement of processes and tools related to document, content, and publishing management. This capability also supports lifecycle management of regulatory applications

About you

Experience:

• 7-10 years with demonstrated leadership in regulatory operations

Soft Skills:

• Expert communication and collaboration skills within a matrixed organization
• Ability to lead, influence, and drive change in a fast-paced, cross-functional environment

Technical skills:

• Expert knowledge of document management systems and submission processes and RIM systems (experience with Veeva Vault, IDMP standards, or similar platforms is required)
• Recognized authority in business process optimization in regulatory affairs
• Expert understanding of capability-based planning, agile delivery, or digital product lifecycles
• Strategic vision for digital tools, automation, or AI implementation

Education:

• Master's preferred plus specialized training

Languages:

• Fluent in English, both spoken and written

Certifications:

•  Advanced certifications plus demonstrated application in LEAN, Agile, BPMN or equivalent

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• 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

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.

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