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 to drive compliance excellence, enhance user experience, and promote process consistency. You will define 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, compliant solutions that support regulatory strategy. Location: Morristown, NJ or 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 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.
• Team-Specific Scope: Registration Tracking, Data Information Flow & Transactions Capability.
• As Business System Owner for Vault RIM RT, ensure alignment between system development and process operationalization in collaboration with the GRO Process Owner and Digital Product Owner.

Qualifications

• 10+ years of demonstrated leadership in regulatory operations.
• Excellent communication and collaboration skills within a matrixed organization; 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 lifecycles.
• Strategic vision for digital tools, automation, and AI implementation.
• Fluent in English (spoken and written).
• Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent preferred.

Skills

• Veeva Vault RIM Registration Tracking and IDMP knowledge
• Regulatory process optimization
• Capability-based planning, agile delivery, and digital product lifecycles
• Strategic use of digital tools, automation, and AI
• Stakeholder engagement and change management
• Cross-functional collaboration

Education

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