Business Analyst Active Dossiers (RIM, Regulatory)-Pharmaceutical

Job Title: Business Analyst Active Dossiers (RIM, Regulatory)
Location: Foster City, CA (Hybrid Onsite Attendance Required)

Job Description

We are seeking a Techno-Functional Business Analyst with experience in Regulatory Information Management (RIM), Active Dossiers, and Regulatory Affairs to join our team in Foster City, CA. This hybrid role requires close collaboration with cross-functional teams, including Regulatory Affairs, Publishing, Labelling, Quality, and IT, to support global regulatory submissions and ensure data integrity across the RIM platform.

The ideal candidate will have hands-on experience with RIM systems such as AgilePV, Veeva RIM, ArisGlobal, or Ennov, and a solid understanding of regulatory submission lifecycles (eCTD/CTD). You will be responsible for gathering requirements, validating regulatory processes, supporting submission tracking, and ensuring compliance through accurate, audit-ready data management.

This position is best suited for a junior to mid-level Business Analyst (5 8 years) with experience in the pharmaceutical or life sciences domain.

Key Responsibilities
Collaborate with Regulatory Affairs and cross-functional teams to gather, analyze, and validate business requirements for RIM and Active Dossier enhancements.
Translate regulatory submission workflows (planning, authoring, compilation, publishing, dispatch, archival) into functional system requirements and process flows.
Support submission management and dossier tracking, ensuring accuracy and compliance of regulatory metadata.
Define user stories, acceptance criteria, functional specifications, and test scenarios for system improvements.
Analyze regulatory data structures, submission lineage, and dossier lifecycle sequences.
Support data remediation efforts to improve metadata quality and submission traceability.
Participate in system validation, regression testing, and controlled releases to ensure compliance with GxP and regulatory standards.
Develop and maintain training materials, user guides, and knowledge base articles for end users.
Provide production support, troubleshoot system issues, and coordinate with IT teams for resolution.
Ensure audit readiness by maintaining traceability and documentation compliance.

Required Skills & Qualifications
Bachelor s degree in Life Sciences, Computer Science, Engineering, or related field.
3 5 years of experience as a Business Analyst in Regulatory Affairs, Life Sciences, or Pharma systems.
Hands-on experience with RIM platforms such as AgilePV, Veeva RIM, ArisGlobal RIMS, or Ennov.
Working knowledge of eCTD/CTD submission structures, sequences, and lifecycle management.
Understanding of EMA, FDA, and ICH submission requirements.
Strong ability to translate regulatory processes into system requirements and business workflows.
Experience creating user stories, functional specs, test cases, and validation documentation.
Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP).
Excellent communication, documentation, and stakeholder-facing skills.

Nice to Have
Experience with RIM system implementations, migrations, or integrations (e.g., RIM to EDMS, publishing tools).
Knowledge of Registration Tracking, Health Authority correspondence, and commitment tracking.
Ability to analyze structured data and ensure metadata quality.
Basic understanding of IDMP data models and regulatory data governance.
Exposure to Computer System Validation (CSV) or 21 CFR Part 11 compliance.

Soft Skills
Strong analytical mindset and attention to detail.
Ability to thrive in cross-functional, matrixed teams.
Proactive approach to problem-solving and root cause analysis.
Comfortable managing multiple priorities under regulatory timelines.
Excellent collaboration and interpersonal skills.

Deliverables
Business and functional requirements documentation.
Process flows, data mapping, and user stories.
Dossier metadata remediation and data quality reports.
End-user training materials and knowledge articles.