Business Analyst

Business Analyst — Active Dossiers (RIM) & Submission Module

Location : Bay Area, CA Onsite / Hybrid (as applicable)

Visa : H4 EAD, H1B, GC & US C

Industry background : Pharma or Medical

Role Overview

The Business Analyst will support Regulatory Information Management (RIM) processes with a primary focus on Active Dossiers and the Submission Management module. The role is responsible for gathering requirements, analyzing end-to-end regulatory workflows, supporting submission lifecycle tracking, and helping ensure accurate, audit-ready data within the RIM platform. This position partners closely with Regulatory Affairs, Publishing, Labeling, Quality, and IT teams to enable compliance, visibility, and timely submissions across global markets.

Key Responsibilities

• Collaborate with Regulatory Affairs stakeholders to gather, document, and validate business requirements for Active Dossier and Submission module enhancements.
• Understand end-to-end regulatory submission lifecycle (planning, authoring, compilation, publishing, dispatch, health authority interactions, archival).
• Support dossier tracking, metadata management, and controlled vocabularies within the RIM repository.
• Analyze dossier data structures, registration records, and submission status to ensure accuracy, completeness, and compliance.
• Define functional requirements, user stories, acceptance criteria, and test scenarios.
• Monitor submission timelines, correspondence, commitments, and regulatory obligations using RIM dashboards.
• Facilitate data remediation efforts to improve dossier lineage, submission sequences, and health authority metadata.
• Support system releases, regression validation, and controlled deployments.
• Develop training materials, user guides and updates as needed.
• Provide end-user support and troubleshoot functional issues.
• Support audits and inspections by ensuring traceability and document readiness.

Required Skills & Experience

Nice-to-Have

Soft Skills

Deliverables

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