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Principal Capability Professional for Registration Tracking xEVMPD

Sanofi
Full-time
Remote friendly (Morristown, NJ)
United States
$147,000 - $212,333.33 USD yearly
Corporate Functions

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Role Summary

Principal Capability Professional for Registration Tracking xEVMPD. Morristown, NJ / Cambridge, MA.

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.
  • 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 workstreams across Regulatory, Digital, and Data Governance.
  • Focus on the end-to-end flow of regulatory registration tracking data across various stages, departments, and systems as BSO for Vault RIM RT.
  • Collaborate with Process Owner (GRO) and Product Owner (Digital) for Registration Tracking and Data Transactions to ensure alignment between system development and process operationalization.

Qualifications

  • Required: 10+ years of leadership in regulatory operations.
  • Preferred: Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent.

Skills

  • Expert knowledge of Veeva Vault RIM Registration Tracking, IDMP standards, and structured data submissions.
  • Proven ability to optimize regulatory business processes.
  • Expert understanding of capability-based planning, agile delivery, and digital product lifecycles.
  • Strategic vision for digital tools, automation, and AI implementation.
  • Strong communication and collaboration skills in a matrixed organization; ability to lead and drive change in a cross-functional environment.

Education

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