Senior Business Analyst – AI-Assisted Regulatory Authoring

We are seeking an experienced Senior Business Analyst to support the end-to-end deployment of an AI-enabled CMC regulatory authoring solution, focused on automation and AI-assisted authoring of CTD/eCTD Module 3 Quality content for NDA/BLA submissions. The consultant will bridge Regulatory CMC scientists/engineers, Quality, IT, AI/Data teams, and technology vendors, translating scientific and regulatory authoring processes into technology requirements and driving business-facing activities across the IT System Development Life Cycle (SDLC)..

Key Responsibilities:

• Lead business analysis for an AI-enabled CMC regulatory authoring technology implementation
• Translate CMC regulatory-authoring workflows into business, functional, data, integration, security, and non-functional requirements
• Support the full SDLC, including discovery, requirements, solution design, build/configuration, testing, UAT, deployment, and stabilization
• Partner directly with Regulatory CMC, scientists, process engineers, and analytical scientists to identify and prioritize authoring automation opportunities
• Define use cases and requirements for Generative AI, LLM/RAG, source-grounded content generation, structured/tabular content automation, content reuse, provenance, and human-in-the-loop review
• Develop user stories, acceptance criteria, process flows, UAT scenarios, and requirements traceability
• Define and execute business acceptance criteria for AI-generated CMC content, including accuracy, completeness, consistency, source alignment, and traceability
• Participate actively in solution-design decisions, challenge assumptions, identify gaps, and recommend practical solutions rather than simply documenting requirements
• Support applicable pharmaceutical IT validation/assurance, deployment readiness, go-live, and post-implementation stabilization

Requirements:

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Computer Science, Information Systems, or a related field; advanced degree a plus
• 7+ years of experience as a business analyst, with demonstrated experience delivering pharmaceutical technology solutions through a formal IT SDLC
• Strong Business Analysis skills, including requirements elicitation, process mapping, user stories, acceptance criteria, UAT, defect management, and requirements traceability
• Experience with Agile methodology, sprints, Jira and Confluence