Principal Capability Professional Registration Tracking xEVMPD
Listed on 2026-01-01
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IT/Tech
Data Analyst, Data Security
Job Title: Principal Capability Professional for Registration Tracking xEVMPD
Location
:
Morristown, NJ/ Cambridge, MA
About the Job:
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
This role leads strategic transformation and innovation of Registration Tracking, Data Information Flow & Transactions Capability by driving compliance excellence, enhancing user experience, and promoting 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.
About Sanofi:
We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main 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.
- 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.
- 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).
- 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 work streams across Regulatory, Digital, and Data Governance.
Registration Tracking, Data Information Flow & Transactions Capability
- Focuses on the end‑to‑end flow of regulatory registration tracking data across various stages, departments, and systems. This includes managing Events, Activities, Regulatory Objectives, Workflows, Wizards, Impact Assessments, and Health Authority Interactions across global procedures and product types.
- Collaborates closely with the Process Owner (GRO) and Product Owner (Digital) for Registration Tracking and Data Transactions to ensure seamless alignment between system development and process operationalization, enabling effective Capability delivery.
- 10 years or more with 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 life cycles.
- Strategic vision for digital tools, automation, and AI…
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