Business Analyst

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Business Analyst Active Dossiers (RIM), Validation, RIM, Regulatory

Location: Hybrid at Foster City, CA

Techno Functional candidate needed with some Pharma/Pharma manufacturing industry exp.. preferred

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, Labelling, 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

3 5 years of experience as a Business Analyst in Regulatory Affairs, Regulatory, or Life Sciences systems.

Hands-on exposure to RIM platforms (AgilePV, Veeva RIM, ArisGlobal RIMS, Ennov, etc.) or equivalent regulatory systems.

Experience working with submission dossiers (eCTD/CTD), sequences, and lifecycle management.

Understanding of EMA, FDA, and ICH regulatory submission requirements.

Strong ability to translate regulatory processes into system requirements and workflows.

Experience writing user stories, functional specifications, test cases, and validation evidence.

Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP preferred).

Excellent communication and stakeholder-facing skills.

Nice-to-Have

Prior system implementation, migration, or integration experience (RIM to EDMS, Publishing tools).

Knowledge of Registration Tracking, HA correspondence, and commitment tracking.

Ability to analyze structured data and metadata quality.

Basic understanding of IDMP data models is a plus.

Soft Skills

Strong analytical mindset and attention to detail.

Ability to thrive in cross-functional, matrixed environments.

Proactive problem-solving and root-cause analysis.

Comfortable managing multiple priorities with regulatory urgency.

Deliverables

Requirements/user story documentation

Process flows and data mapping

Dossier metadata remediation reports

End-user training assets and knowledge articles