Principal Capability Professional for Registration Tracking xEVMPD
- 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 s upport 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.
- 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 lifecycles.
- Strategic vision for digital tools, automation, and AI implementation.
- BS/BA is required
- Master's degree or specialized training is preferred
- Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent preferred
- Fluent in English (spoken and written).
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-SA
#LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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