Job Title

Job Summary: We are looking for an experiencedRegulatory Business Analystwith strong hands-on experience inVeeva Vault RIMto support regulatory operations and digital transformation initiatives within the pharmaceutical domain. The ideal candidate should have a deep understanding of regulatory processes and documentation, and be capable of working closely with regulatory affairs teams, IT, and vendors to drive system implementation and optimization. Key Responsibilities: Gather and document business and functional requirements related to regulatory systems and workflows. Act as a liaison betweenRegulatory AffairsandIT teams , translating business needs into actionable system enhancements. Drive implementation and optimization ofVeeva Vault RIMmodules: Submissions, Registrations, Submissions Archive, and Product. Analyze existing regulatory processes and recommend digitization/improvement opportunities. Support data migration, configuration, validation, and user acceptance testing (UAT) of Veeva Vault RIM. DocumentBRD, FRD, use cases, process flows , andtraceability matrices . Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH). Work in collaboration with cross-functional teams (Quality, RA Ops, IT, Vendors) across geographies. Required Skills & Qualifications: 6+ years of experience as aBusiness Analystin thePharmaceutical or Life Sciencesdomain. Minimum 2 years hands-on experienceinVeeva Vault RIM(Submissions/Registrations/Product modules). Strong understanding ofRegulatory Affairs processes : submission lifecycle, labeling, lifecycle management, compliance. Proven experience inrequirement gathering, documentation, and stakeholder management . Familiarity witheCTD, IDMP, XEVMPD , andGxP compliance . Experience withCSV/validation supportis a plus. Excellent communication, presentation, and analytical skills. Nice-to-Have: Experience with other regulatory systems (e.g., ArisGlobal, Lorenz docuBridge, MasterControl). Exposure to Agile/Scrum methodologies. Knowledge ofVeeva Vault Quality or PromoMatsis a bonus.