Functional Analyst - RIM

Functional Analyst – Regulatory Information Management (RIM)

Zensar Technologies | Healthcare & Life Sciences Practice Experience: 4–5 Years | Role Type: Functional / Business Analyst (Non-Configuration)

Role Overview

Zensar Technologies is seeking a Functional Analyst with 4–5 years of hands-on experience in Regulatory Information Management to join its Healthcare & Life Sciences (HLS) practice. This is a non-configuration, business-facing role focused on translating complex regulatory workflow requirements into functional specifications, supporting Veeva Vault RIM implementations, and acting as the primary bridge between client regulatory affairs teams and technical delivery squads.

The ideal candidate brings a deep understanding of regulatory submission lifecycles, dossier management, and global health authority requirements — paired with strong stakeholder management and documentation skills.

Key Responsibilities

Regulatory Process Analysis & Documentation

• Conduct detailed discovery sessions with client regulatory affairs, RA operations, and IT stakeholders to elicit, validate, and document current-state and future-state processes.
• Author functional specifications, BRDs, use cases, user stories, and process flow diagrams for Veeva Vault RIM modules (Submissions, Submissions Archive, Registrations, Submissions Publishing).
• Maintain requirements traceability matrices (RTMs) throughout project delivery to ensure full coverage from business need to acceptance criteria.

Veeva Vault RIM Engagement

• Support end-to-end Veeva Vault RIM implementations in a functional capacity — from requirements through UAT — without direct system configuration.
• Coordinate with Vault administrators and configuration teams to ensure design decisions align with documented functional requirements.
• Review configured workflows, document structures, and object relationships to validate functional accuracy against approved specifications.
• Facilitate walkthrough sessions and configuration reviews with client stakeholders.

Regulatory Domain Support

• Apply working knowledge of regulatory submission types (NDA, BLA, MAA, IND, IMPD, CTD/eCTD) to contextualize solution design discussions.
• Understand global health authority requirements (FDA, EMA, CDSCO, PMDA) and their impact on document management, submission timelines, and registration workflows.
• Map client regulatory SOPs to platform capabilities and identify gaps requiring process change or workaround solutions.

Testing & Quality Assurance

• Develop comprehensive UAT test plans, test scripts, and acceptance criteria in alignment with GxP and 21 CFR Part 11 requirements.
• Lead or support UAT execution cycles, defect triage sessions, and sign-off processes with business stakeholders.
• Ensure test evidence is documented in a manner suitable for audit and regulatory inspection.

Training & Change Management

• Develop role-based training materials, quick reference guides, and SOPs for end-user adoption of Veeva Vault RIM.
• Facilitate training sessions for regulatory operations, submission management, and registration teams.
• Support change impact assessments and contribute to change management planning alongside project managers.

Required Skills & ExperienceSkill / DomainExpectationVeeva Vault RIMFunctional knowledge of Submissions, Registrations, Submissions Archive modules; no config requiredRegulatory Affairs BackgroundUnderstanding of eCTD structure, dossier management, submission lifecycle, global RA operationsBusiness AnalysisBRD / FSD authoring, process mapping, user story writing, RTM maintenanceGxP & ComplianceWorking knowledge of 21 CFR Part 11, Annex 11, and GxP documentation principlesUAT LeadershipTest plan development, script authoring, defect management, stakeholder sign-offStakeholder ManagementComfortable in client-facing roles; ability to run workshops, demos, and review sessionsToolsJIRA, Confluence, MS Office Suite, Visio / Lucidchart for process flowsCommunicationClear, structured written and verbal communication with both business and technical audiencesPreferred Qualifications

• Exposure to Veeva Vault eTMF or QualityDocs in addition to RIM modules.
• Familiarity with IDMP standards and their impact on regulatory data models.
• Experience working in Agile/Scrum delivery environments alongside configuration and technical teams.
• Knowledge of publishing tools such as Lorenz docuBridge, Extedo eCTD Manager, or similar.
• Prior engagement in a CRO, CDMO, pharma IT service provider, or consulting firm context.
• Life sciences domain certification (e.g., RAC, RAPS membership) is a plus.

ResponsibilitiesKey Responsibilities

Regulatory Process Analysis & Documentation

• Conduct detailed discovery sessions with client regulatory affairs, RA operations, and IT stakeholders to elicit, validate, and document current-state and future-state processes.
• Author functional specifications, BRDs, use cases, user stories, and process flow diagrams for Veeva Vault RIM modules (Submissions, Submissions Archive, Registrations, Submissions Publishing).
• Maintain requirements traceability matrices (RTMs) throughout project delivery to ensure full coverage from business need to acceptance criteria.

Veeva Vault RIM Engagement

• Support end-to-end Veeva Vault RIM implementations in a functional capacity — from requirements through UAT — without direct system configuration.
• Coordinate with Vault administrators and configuration teams to ensure design decisions align with documented functional requirements.
• Review configured workflows, document structures, and object relationships to validate functional accuracy against approved specifications.
• Facilitate walkthrough sessions and configuration reviews with client stakeholders.

Regulatory Domain Support

• Apply working knowledge of regulatory submission types (NDA, BLA, MAA, IND, IMPD, CTD/eCTD) to contextualize solution design discussions.
• Understand global health authority requirements (FDA, EMA, CDSCO, PMDA) and their impact on document management, submission timelines, and registration workflows.
• Map client regulatory SOPs to platform capabilities and identify gaps requiring process change or workaround solutions.

Testing & Quality Assurance

• Develop comprehensive UAT test plans, test scripts, and acceptance criteria in alignment with GxP and 21 CFR Part 11 requirements.
• Lead or support UAT execution cycles, defect triage sessions, and sign-off processes with business stakeholders.
• Ensure test evidence is documented in a manner suitable for audit and regulatory inspection.

Training & Change Management

• Develop role-based training materials, quick reference guides, and SOPs for end-user adoption of Veeva Vault RIM.
• Facilitate training sessions for regulatory operations, submission management, and registration teams.
• Support change impact assessments and contribute to change management planning alongside project managers.

QualificationsPreferred Qualifications

• Exposure to Veeva Vault eTMF or QualityDocs in addition to RIM modules.
• Familiarity with IDMP standards and their impact on regulatory data models.
• Experience working in Agile/Scrum delivery environments alongside configuration and technical teams.
• Knowledge of publishing tools such as Lorenz docuBridge, Extedo eCTD Manager, or similar.
• Prior engagement in a CRO, CDMO, pharma IT service provider, or consulting firm context.
• Life sciences domain certification (e.g., RAC, RAPS membership) is a plus.

About UsAt Zensar, we’re “experience-led everything”. We are committed to conceptualizing, designing, engineering, marketing, and managing digital solutions and experiences for over 130 leading enterprises. We are a company driven by a bold purpose: Together, we shape experiences for better futures. Whether for our clients, our people, or the world around us, this belief powers everything we do. At the heart of our culture is ONE with Client - a set of four core values that reflect who we are and how we work: One Zensar, Nurturing, Empowering, and Client Focus.
Part of the $4.8 billion RPG Group, we’re a community of 10,000+ innovators across 30+ global locations, including Milpitas, Seattle, Princeton, Cape Town, London, Zurich, Singapore, and Mexico City. Explore Life at Zensar and join us to Grow. Own. Achieve. Learn. to be the best version of yourself.
We believe the best work happens when individuality is celebrated, growth is encouraged, and well-being is prioritized. We are an equal employment opportunity (EEO) and affirmative action employer, committed to creating an inclusive workplace. All qualified applicants will be considered without regard to race, creed, color, ancestry, religion, sex, national origin, citizenship, age, sexual orientation, gender identity, disability, marital status, family medical leave status, or protected veteran status.