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CMC IT Business Analyst Consultant
Focus: CMC Regulatory Authoring | AI & Data | CTD Module 3 | SDLC
LABUR is partnering with a client to hire a CMC IT Business Analyst Consultant who will support the end-to-end deployment of an AI-enabled CMC regulatory authoring solution. This engagement centers on automation and AI-assisted authoring of CTD/eCTD Module 3 Quality content for NDA/BLA submissions. The consultant will serve as the critical bridge between Regulatory CMC scientists and engineers, Quality, IT, AI/Data teams, and technology vendors, translating scientific and regulatory authoring processes into actionable technology requirements and driving business-facing activities across the IT System Development Life Cycle (SDLC). This role demands a blend of CMC/regulatory domain knowledge and proven technology delivery experience, not generic Business Analysis experience alone.
Responsibilities
Lead business analysis for an AI-enabled CMC regulatory authoring technology implementation, actively participating in solution-design decisions, challenging assumptions, identifying gaps, and recommending practical solutions.
Translate CMC regulatory-authoring workflows into business, functional, data, integration, security, and non-functional requirements.
Support the full SDLC, including discovery, requirements gathering, solution design, build/configuration, testing, UAT, deployment, and stabilization.
Partner directly with Regulatory CMC stakeholders, 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 and tabular content automation, content reuse, provenance, and human-in-the-loop review.
Develop user stories, acceptance criteria, process flows, UAT scenarios, and maintain full requirements traceability.
Define and execute business acceptance criteria for AI-generated CMC content, covering accuracy, completeness, consistency, source alignment, and traceability.
Support pharmaceutical IT validation and assurance activities, deployment readiness, go-live execution, and post-implementation stabilization.
Qualifications
Demonstrated experience delivering pharmaceutical technology solutions through a formal IT SDLC.
Strong Business Analysis capabilities, including requirements elicitation, process mapping, user stories, acceptance criteria, UAT, defect management, and requirements traceability.
Proficiency with Agile methodology, sprint ceremonies, Jira, and Confluence.
Practical understanding of CMC regulatory documentation and CTD/eCTD Module 3, including 3.2.S (Drug Substance) and/or 3.2.P (Drug Product), structured and tabular CMC information, manufacturing process descriptions, analytical methods, specifications, control strategies, stability data, and process validation and characterization information. Must understand how scientific and manufacturing information progresses from source data into CMC regulatory submission content.
Proven track record partnering with CMC scientists, engineers, analytical scientists, and Regulatory CMC stakeholders.
Ability to translate complex scientific and regulatory processes into implementable technology requirements.
Demonstrated analytical thinking with the ability to evaluate alternatives, challenge assumptions, and influence solution decisions.