Principal Capability Professional Registration Tracking xEVMPD

Role Summary

Principal Capability Professional for Registration Tracking xEVMPD leads strategic transformation and innovation of Registration Tracking, Data Information Flow & Transactions Capability, driving compliance excellence, user experience, and process consistency. Defines and drives cross-domain capability roadmaps with enterprise impact, serving as a strategic bridge between regulatory SMEs, business process owners, and digital product teams to develop scalable, compliant solutions that support regulatory strategy.

• 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.
• Focus on end-to-end flow of regulatory registration tracking data across stages, departments, and systems; manage Events, Activities, Regulatory Objectives, Workflows, Wizards, Impact Assessments, and Health Authority Interactions.
• Collaborate with Process Owner (GRO) and Product Owner (Digital) for alignment between system development and process operationalization.
• Lead cross-functional initiatives to enable effective Capability delivery.

• Experience:
  
  10+ years with demonstrated leadership in regulatory operations.
• Soft Skills:
  
  Expert communication and collaboration 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 life cycles; strategic vision for digital tools, automation, and AI implementation.
• Languages:
  
  Fluent in English (spoken and written).

• Business process optimization in regulatory affairs
• Capability-based planning and agile delivery
• Digital product life cycles and AI implementation
• Veeva Vault RIM Registration Tracking and IDMP standards
• Regulatory data governance and submission readiness

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

• Advanced certifications in LEAN, Agile, BPM or equivalent preferred

• None specified beyond job-related qualifications.