Experience: 10+ Years
Primary Skills: Veeva Vault RIM, Regulatory Affairs, Regulatory Submissions, Vault Configuration
Role Type: Technical / Functional Lead
We are seeking an experienced Senior Veeva Vault RIM Consultant / Lead to drive the implementation, configuration, enhancement, and support of the Veeva Vault Regulatory Information Management (RIM) Suite. The ideal candidate will have strong expertise in regulatory information management, global regulatory submissions, registrations, and compliance-driven system implementations.
The candidate will collaborate with Regulatory Affairs, Clinical, Quality, and IT teams to translate business requirements into scalable solutions, manage regulatory data and workflows, and ensure compliance with applicable GxP and global regulatory standards.
Lead the implementation, configuration, and support of Veeva Vault RIM modules, including Registrations, Submissions, Submissions Archive, and RegulatoryOne.
Partner with Regulatory Affairs, Clinical, Quality, and IT stakeholders to gather requirements, conduct fit-gap analysis, and design effective RIM solutions.
Support the end-to-end lifecycle of global regulatory submissions, product registrations, renewals, variations, and health authority correspondence.
Configure and maintain Veeva Vault objects, document types, lifecycles, workflows, security roles, metadata, and reporting capabilities.
Lead regulatory data migration from legacy systems to Veeva Vault RIM, ensuring data accuracy, completeness, traceability, and compliance.
Support integrations between Veeva RIM and enterprise platforms, including Veeva Quality, Veeva Safety, Veeva Clinical, SAP, ERP systems, Documentum, and other regulatory repositories.
Develop and execute system validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), Requirements Traceability Matrices (RTM), and IQ/OQ/PQ documentation.
Ensure system configuration, validation, and testing activities align with GxP requirements, FDA 21 CFR Part 11, EMA guidelines, and applicable global regulatory requirements.
Identify opportunities to improve regulatory operations through process standardization, automation, and workflow optimization.
Provide production support, troubleshoot system issues, perform root-cause analysis, and coordinate release management and system enhancements.
Plan and execute functional testing, regression testing, UAT, and post-release validation activities.
Develop user guides, process documentation, and training materials; conduct end-user training as required.
Serve as a subject matter expert (SME) for Veeva Vault RIM, advising stakeholders on regulatory data management, system capabilities, implementation best practices, and future enhancements.
Coordinate with technical teams and vendors to ensure timely issue resolution and delivery of system improvements.
10+ years of relevant professional experience, with substantial hands-on experience in Veeva Vault RIM implementations and support.
Strong knowledge of Veeva Vault RIM modules, including Registrations, Submissions, Submissions Archive, and RegulatoryOne.
Experience in global regulatory submissions, registrations, renewals, variations, and regulatory correspondence.
Hands-on configuration experience with Vault objects, document types, lifecycles, workflows, permissions, metadata, and reports.
Knowledge of regulatory data migration, data mapping, reconciliation, and integration processes.
Experience preparing validation documentation, including URS, FS, RTM, IQ/OQ/PQ, and test scripts.
Understanding of GxP compliance, FDA 21 CFR Part 11, and global regulatory requirements.
Experience in production support, incident management, release management, testing, and user training.
Strong business analysis, stakeholder management, troubleshooting, and solution design skills.
Experience integrating Veeva RIM with Veeva Quality, Safety, or Clinical applications.
Exposure to SAP, ERP systems, Documentum, and other enterprise regulatory repositories.
Experience with Veeva Vault Platform administration and configuration.
Familiarity with Veeva CRM.
Experience supporting global pharmaceutical, biotechnology, or life sciences organizations.
Knowledge of regulatory process optimization and enterprise system integration.
Strong communication and stakeholder management.
Excellent analytical and problem-solving abilities.
Ability to lead workshops, requirements discussions, and solution design sessions.
Strong ownership of deliverables and issue resolution.
Ability to mentor team members and coordinate cross-functional activities.
Clear documentation and presentation skills.
