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Lead Business Analyst
2 weeks ago
Job Summary:
We are looking for an experienced Regulatory Business Analyst with strong hands-on experience in Veeva Vault RIM to 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 between Regulatory Affairs and IT teams , translating business needs into actionable system enhancements.
- Drive implementation and optimization of Veeva Vault RIM modules: 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.
- Document BRD, FRD, use cases, process flows , and traceability 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 a Business Analyst in the Pharmaceutical or Life Sciences domain.
- Minimum 2 years hands-on experience in Veeva Vault RIM (Submissions/Registrations/Product modules).
- Strong understanding of Regulatory Affairs processes : submission lifecycle, labeling, lifecycle management, compliance.
- Proven experience in requirement gathering, documentation, and stakeholder management .
- Familiarity with eCTD, IDMP, XEVMPD , and GxP compliance .
- Experience with CSV/validation support is 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 of Veeva Vault Quality or PromoMats is a bonus.
