Principal Capability Professional for Registration Tracking xEVMPD

Role Summary

Location: Morristown, NJ / Cambridge, MA. Principal Capability Professional for Registration Tracking xEVMPD leads strategic transformation and innovation of Registration Tracking, Data Information Flow & Transactions Capability to drive compliance excellence, enhance user experience, and promote process consistency. You will define and drive cross-domain capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead the development of scalable and compliant solutions that support Sanofi regulatory strategy.

Responsibilities

• Strategic Capability Leadership: 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.
• Compliance & Operational Excellence: 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.
• System & Data Ownership: 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.
• Digital Transformation & Innovation: Evaluate and champion strategic technology investments in regulatory capability development, digital adoption, and AI; analyze Veeva releases and roadmap critical features for future adoption; contribute to structured data submission readiness (gradual IDMP implementation in multiple regions, such as PMS enrichment for Europe).
• Stakeholder Engagement & Enablement: Design enterprise change management frameworks and governance with Training and Communication teams; facilitate Functional Lead forums and present best practices to Super Users; develop talent and lead workstreams across Regulatory, Digital, and Data Governance.
• Team-Specific Scope: Registration Tracking, Data Information Flow & Transactions Capability — As Business System Owner for Vault RIM RT: Focus on the end-to-end flow of regulatory registration tracking data across various stages, departments, and systems, including managing Events, Activities, Regulatory Objectives, Workflows, Wizards, Impact Assessments, and Health Authority Interactions across global procedures and product types; collaborate with the Process Owner (GRO) and Product Owner (Digital) for Registration Tracking and Data Transactions to ensure alignment between system development and process operationalization, enabling effective capability delivery.

Qualifications

• About You: 10 years or more with demonstrated leadership in regulatory operations.

Skills

• Soft Skills: Expert communication and collaboration skills within a matrixed organization. Proven ability to lead, influence, and drive change in a fast-paced, cross-functional environment.
• Technical Skills: 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.
• Languages: Fluent in English (spoken and written).

Education

• BS/BA is required
• Master's degree or specialized training is preferred
• Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent preferred