Support Analyst delivering technical support for Totvs Datasul systems and enhancing internal processes. Seeking proactive professionals in technology fields for improvement initiatives.
About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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