Senior Capability Analyst at Sanofi managing regulatory capabilities and compliance. Leading cross-domain roadmap and digital transformation initiatives for global regulatory strategy.
Responsibilities
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
Requirements
7-10 years with demonstrated leadership in regulatory operations
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
Master's preferred plus specialized training
Fluent in English, both spoken and written
Advanced certifications plus demonstrated application in LEAN, Agile, BPMN or equivalent
Benefits
High-quality healthcare
Prevention and wellness programs
Gender-neutral parental leave of at least 14 weeks
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