• Determine business requirements, focusing on a solution or part of a solution, and document them. • Explore solution-related risks, external factors, assumptions, constraints, etc. • Suggest design options and improvements for the To Be state of a solution. • Conduct stakeholder analysis (roles, responsibilities, influence, attitude, preferences for the identified internal and external stakeholders). • Outline communication rules, escalation path, and keep up to date with the BA-related meetings schedule. • Prepare for and conduct elicitation sessions using different techniques and their combinations (e.g., surveys, observations, group interviews, document analysis, interface analysis, etc.) • Explain the business context of a solution to the development team and other relevant stakeholders. • Discuss solution requirements and design options with the team, and communicate outcomes to the client (incl. business context, tech dependencies, constraints, risks, benefits, and opportunities). • Escalate requirements conflicts to the relevant stakeholders and track their resolutions. • Work on both functional and non-functional requirements specification and documentation (e.g., user story with acceptance criteria, use-cases, feature document, quality attribute scenario, etc.) • Support both functional and non-functional requirements with appropriate models and visuals (e.g., diagrams, matrices, mockups, wireframes, calculation models). • Verify both functional and non-functional requirements and models with the team and client. • Create a verification checklist if needed. • Validate both functional and non-functional requirements against the business needs, goals, and objectives of a particular solution. • Outline scope boundaries of a module or feature (e.g., in- and out-of-scope, functional decomposition, use case diagrams, models, etc.) • Prioritize solution requirements using simple classification techniques. • Use traceability to ensure requirements coverage and to analyze requirements changes. • Obtain stakeholders' approval for solution requirements. • Maintain solution requirements and their attributes. • Assess the impact of the identified requirements changes, document and communicate changes and their implications to relevant stakeholders. • Collect feedback on implemented solution or solution component using multiple sources of information: demo, UAT, defects, user support requests, etc.

• Develop and maintain strategic roadmap for Partner capabilities enhancements and initiatives • Drive Partner Capabilities system roadmap evolution to support strategic objectives • Align with Go-to-Market teams on business priorities and policy implementation • Gather business requirements for new enhancements and initiatives • Serve as primary subject matter expert and escalation point for designated Partner capabilities • Manage system improvement lifecycle from discovery to implementation with stakeholder alignment • Implement data governance processes to ensure system performance and data integrity • Establish KPIs (adoption rates, SLAs, support metrics) to identify optimization opportunities • Troubleshoot and resolve system defects and technical issues • Monitor system workflows to ensure stability and optimal performance • Create and maintain comprehensive system documentation and logical workflows • Coordinate cross-functional documentation of processes and Partner integration workflows • Collaborate with IT on requirements, documentation, user stories, testing, and training • Lead change management, including training materials and transition documentation

• Configuring, administering, and supporting Veeva Vault RIM environments across the Registrations, Submissions, Publishing, and Archive modules for client engagements. • Delivering implementation, migration, and ongoing managed services support that keeps client RIM environments compliant, reliable, and continuously improved. • Translating evolving regulatory and eCTD requirements into system configuration changes in partnership with the Regulatory Intelligence Practice Lead. • Acting as the technical point of contact for client-reported issues, configuration requests, and release management activities. • Configure and maintain Vault objects: document types, fields, page layouts, picklists, and object hierarchies within Vault RIM. • Design and configure lifecycle and workflow states, entry/exit actions, user actions, and role-based state transitions. • Build and maintain security profiles, permission sets, and role-based access matrices within the Vault Admin console. • Support data migration and bulk record management using Vault Loader, including data mapping, transformation, and load validation. • Configure and maintain Vault-to-Vault and third-party integrations via Vault REST/SOAP APIs and SFTP-based data exchanges (e.g., Safety, Quality, ERP systems). • configure RIM Registrations: application/product hierarchies, registration and license record structures, and health authority correspondence tracking. • Configure RIM Submissions: Submission Content Plans, eCTD lifecycle metadata, sequence structures, and document-to-section mapping. • Configure RIM Publishing: rendition profiles, binder/output templates, and publishing configuration supporting eCTD and NeeS output. • Manage sandbox refreshes, regression testing, and release notes review for Veeva's biannual release cycles. • Coordinate user acceptance testing (UAT) and promotion of configuration changes from sandbox to production. • Triage, troubleshoot, and resolve Tier 2/3 support tickets for client-managed RIM environments. • Perform periodic system health checks and proactively identify configuration or performance risks. • Document configuration specifications, business requirements, and SOPs for client-facing and internal use. • Support end-user training and enablement on Vault RIM functionality.

• Serving as the primary liaison between Regulatory Affairs/Operations business stakeholders and IT/platform teams, translating regulatory business needs into system requirements and configuration specifications. • Supporting implementation, migration, and ongoing managed services engagements across Regulatory Information Management (RIM) platforms, independent of underlying vendor (e.g., Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS). • Facilitating requirements gathering, process mapping, and vendor-neutral system evaluation to support client regulatory technology strategy and roadmap decisions. • Acting as the functional point of contact for client-reported issues, enhancement requests, and release management activities, coordinating with technical configuration and IT teams to deliver resolution. • Own intake, triage, and prioritization of managed services requests and tickets across client RIM environments, regardless of platform. • Support release management processes, including regression testing coordination, UAT script development and execution, and release notes review, for whichever RIM or adjacent platform a client operates. • Identify and document process improvement and automation opportunities across the regulatory technology landscape. • Maintain SOPs, business process documentation, and system configuration specifications for client-facing and internal use.