Principal Capability Professional for Registration Tracking xEVMPD

Role Summary

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

Responsibilities

• Strategic Capability Leadership: Define and drive cross-domain capability roadmaps with enterprise impact; contribute to enterprise-level process architecture and governance; design and orchestrate workshop programs and testing strategies.
• Compliance & Operational Excellence: Develop enterprise compliance strategies and risk mitigation; represent the organization during 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 for Veeva RIM; oversee governance and documentation; manage Registration Tracking backlog in JIRA; 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 features for future adoption; contribute to data submission readiness (IDMP implementation in multiple regions).
• Stakeholder Engagement & Enablement: Design enterprise change management frameworks and governance with Training and Communication teams; facilitate Functional Lead forums and present best practices; develop talent and lead workstreams across Regulatory, Digital, and Data Governance.
• Team-Specific Scope: Registration Tracking, Data Information Flow & Transactions Capability; act as Business System Owner for Vault RIM RT, focusing on end-to-end flow of regulatory registration tracking data across stages, departments, and systems; collaborate with Process Owner and Product Owner to align system development with process operation.

Qualifications

• Required: 10 years or more of demonstrated leadership in regulatory operations; executive-level ability to lead, influence, and drive change in a fast-paced, cross-functional environment.
• Preferred: Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent.

Skills

• Soft Skills: Expert communication and collaboration within a matrixed organization; ability to lead, influence, and drive change.
• Technical Skills: Expert knowledge of Veeva Vault RIM Registration Tracking, IDMP standards, and structured data submissions; authority in business process optimization in regulatory affairs; strong understanding of capability-based planning, agile delivery, and digital product lifecycles; strategic vision for digital tools, automation, and AI implementation.

Education

• BS/BA required
• Master's degree or specialized training preferred

Certifications

• Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent preferred

Languages

• Fluent in English (spoken and written)