Principal Capability Professional for Registration Tracking xEVMPD

About This Role

This role drives strategic transformation and innovation for Registration Tracking, Data Information Flow & Transactions Capability by enhancing compliance excellence, user experience, and process consistency. The Principal Capability Professional will define cross-domain capability roadmaps with enterprise impact, bridge regulatory SMEs and digital product teams, and develop scalable solutions supporting Sanofi's regulatory strategy.

Responsibilities

• Define and drive cross-domain capability roadmaps with enterprise impact
• Contribute to enterprise-level process architecture and governance, balancing standardization and innovation
• Design and orchestrate complex workshop programs and testing strategies to support solution development and validation
• Develop enterprise compliance strategies and risk mitigation approaches
• Represent the organization during critical audits and regulatory inspections related to Registration Tracking and Data Information Flow Capability
• Drive transformational process improvements with significant ROI across end-to-end regulatory capabilities
• Serve as Business System Owner (BSO) for Veeva RIM, overseeing governance, documentation, and strategic alignment
• Manage Registration Tracking backlog in JIRA and triage against Back to Standard Program
• Lead resolution of Level 3 support issues and complex modeling challenges
• Evaluate and champion strategic technology investments in regulatory capability development, digital adoption, and AI

Requirements

• 10+ years of demonstrated leadership in regulatory operations
• Expert communication and collaboration skills within a matrixed organization
• Proven ability to lead, influence, and drive change in a fast-paced, cross-functional environment
• Expert knowledge of Veeva Vault RIM Registration Tracking, IDMP standards, and structured data submissions
• Recognized authority in business process optimization in regulatory affairs
• Expert understanding of capability-based planning, agile delivery, and digital product lifecycles
• Strategic vision for digital tools, automation, and AI implementation

Qualifications

• BS/BA is required, Master's degree or specialized training is preferred
• 10+ years of demonstrated leadership in regulatory operations

Nice to Have

• Master's degree or specialized training
• Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent

Skills

* Required skills

Benefits