Global Regulatory Operations - Regulatory Digital Data & AI
Job title: Senior Capability Analyst
- Grade: 3.1
- Location: Gentilly, FR
- Job type: Permanent, Full time
About Sanofi
At Sanofi, we chase the miracles of science to improve people's lives. We are committed to transforming the practice of medicine through scientific breakthroughs that benefit society. Our Regulatory Affairs function plays a critical role in this mission, ensuring that our innovations reach patients safely and efficiently.
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 the job
Sanofi is committed to creating an inclusive workplace that embraces diversity of thought, background, and experience. We believe that a diverse team strengthens our ability to innovate and better serve our patients worldwide.
Main responsibilities:
This role drives strategic execution and transformation of regulatory content management by leading compliance initiatives, enhancing user experience, and promoting process consistency—while actively driving innovation, digital transformation, and operational excellence. As a Senior Capability Analyst, you will lead development and execution of capability roadmaps within your domain, serve as a key bridge between regulatory subject matter experts, business process owners, and digital product teams, and develop scalable and compliant solutions.
Key responsibilities include:
- Lead development and execution of capability roadmaps within domain
- Design and optimize process and information architecture, balancing standardization and innovation needs
- Lead workshops, design sessions, and business testing activities to support solution development and validation
- Establish compliance frameworks and audit protocols by maintaining accurate records and documentation
- Conduct comprehensive analysis and translate into business solutions
- Develop and implement process improvements with measurable impact across end-to-end regulatory capabilities
- Lead preparation for audits and inspections for the capability
- Work with Digital Product Owners, Business Process Owners, and SMEs to drive capability adoption
- Drive capability adoption and change management strategies with the Training/Development and Communication teams
- Research and recommend emerging technologies and trends in regulatory capability development, digital adoption, and AI in life sciences
- Mentor junior team members
- 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:
- Grade 3.1: 5-7 years with demonstrated expertise in regulatory operations
- Soft Skills:
- Advanced communication and collaboration skills within a matrixed organization
- Ability to lead and influence in a fast-paced, cross-functional environment
- Technical skills:
- Advanced knowledge of document management systems and submission processes and RIM systems (experience with Veeva Vault, IDMP standards, or similar platforms is required)
- Expert understanding in business process analysis in regulatory affairs
- Advanced understanding of capability-based planning, agile delivery, or digital product lifecycles
- Proficiency with digital tools, automation, or AI
- Education:
- Grade 3.1: Bachelor's degree required, Master's preferred
- Languages: Fluent in English, both spoken and written
- Certifications:
- Grade 3.1: LEAN, Agile, BPMN or equivalent certifications preferred
-
Skills:
Technical Functional Transversal Other
International
Regulatory
Compliance
(Experienced),
Business Technology
(Advanced),
Artificial Intelligence
(AI) (Advanced),
Digital Adoption
(Advanced) Technology
Implementations
(Advanced),
Project Management
(Advanced),
Operational
Efficiency
(Experienced), Data
Analytics
(Experienced),
Design Thinking
(Advanced) Cross-Functional
Teamwork
(Experienced) Stakeholder
Relationship
Management
(Experienced)
