R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt
Senior Capability Analyst
Marcy-l'Étoile, Frankreich Salary Range EUR 54,400.00 - 72,533.33
Auf einen Blick:
Bringe deine Neugier in ein Team ein, in dem echte Wissenschaft in der Immunologie auf bahnbrechende Innovation trifft. Ob Onkologie, seltene Krankheiten, Neurologie oder Impfstoffe – hier arbeitest du an der Schnittstelle von Laborwissenschaft und KI-gestützter Forschung. Und das immer gemeinsam mit anderen, um wegweisende Ideen in echte Wirkung zu verwandeln. Egal, ob du dein wissenschaftliches Know-how vertiefen oder dich als Führungskraft weiterentwickeln willst – hier findest du die Chance dazu.
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)
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.
#LI-FRA
#LI-Hybrid
Pursue Progress. Discovery Extraordinary.
Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.
Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.
Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und anderer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an Benefits-Programmen teilzunehmen.
Mehr Informationen über diesen Standort
Warum mit uns arbeiten?
- Erweitere deinen Horizont. Wachse durch Neugier – mit Unterstützung, um dich weiterzuentwickeln, Neues zu lernen und Verantwortung zu übernehmen. In einer Kultur, die Mentoring, Mobilität und mutige Entwicklung großschreibt.
- Beschleunige Ergebnisse mit Technologie. Nutze die Power von KI und Automatisierung, um wissenschaftliche Grenzen zu verschieben und neue Wege in der Arzneimittelforschung zu gehen.
- Gestalte Innovationen, die wirklich zählen. Hilf mit, bessere Wissenschaft und fairere Ergebnisse zu erzielen – durch inklusive Forschung, die mehr Menschen auf bedeutende Weise erreicht.
- Mach aus Patient*innen-Bedürfnissen bahnbrechende Wissenschaft. Arbeite an wissenschaftlichen Durchbrüchen, die bei den Bedürfnissen der Patient*innen starten – und in Therapien enden, die Leben verändern.
Lerne Nils Libert kennen, Associate Scientist
Triff Nils Libert, Associate Scientist in Belgien, der eine wichtige Rolle dabei spielt, bahnbrechende Forschung voranzutreiben. Erfahre, wie seine Arbeit Innovationen fördert, neue wissenschaftliche Möglichkeiten entdeckt – und dazu beiträgt, lebensverändernde Therapien zu entwickeln, die das Leben von Patient*innen weltweit verbessern.
"Bei Sanofi bauen wir eine F&E-Maschine auf, die von bester Wissenschaft, digitaler Innovation und dem festen Willen angetrieben wird, das Leben von Patient*innen weltweit zu verändern."
Houman Ashrafian
EVP & Head of R&D
Mehr entdecken
Unsere F&E-Schwerpunkte
Finde heraus, wie wir die Zukunft der Medizin neu gestalten – mit -Wissenschaft in der Immunologie, die mutige, krankheitsübergreifende Durchbrüche möglich macht, die vor zehn Jahren noch undenkbar waren.
Lerne unsere Teams in den Laboren kennen
Schau in unsere Labore rein und höre direkt von den Wissenschaftler*innen, die modernste Wissenschaft in echte Ergebnisse verwandeln – angetrieben von Neugier, Teamgeist und Sinn.
Mach mit bei unserer Talent Community
Was können wir gemeinsam erreichen? Unsere Teams arbeiten an Projekten, die Menschenleben nachhaltig verändern. Registriere Dich jetzt und erhalte die neuesten Stellenangebote, sobald diese veröffentlicht werden.