Business Analyst - CMC Regulatory Authoring | AI & Data | CTD Module 3 | SDLC
Location : Cambridge, Boston ( wkly 3 days in Office)
Focus: CMC Regulatory Authoring | AI & Data | CTD Module 3 | SDLC
Role Summary
Seeking an experienced CMC IT Business Analyst Consultant 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).
This role requires a combination of CMC/regulatory domain knowledge and proven technology delivery experience, not generic Business Analysis experience alone.
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.
Required Qualifications
• 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
• Practical understanding of CMC regulatory documentation and CTD/eCTD Module 3, including 3.2.S – Drug Substance and/or 3.2.P – Drug Product, associated structured/tabular CMC information,
manufacturing process descriptions, analytical methods, specifications, control strategies, stability information, process validation and characterization information. Candidate should understand
how scientific and manufacturing information progresses from source data and technical documentation into CMC regulatory submission content.
• Experience working with CMC scientists, engineers, analytical scientists, and/or Regulatory CMC stakeholders.
• Ability to translate complex scientific/regulatory processes into implementable technology requirements.
• Demonstrated ability to analyze issues, evaluate alternatives, challenge assumptions, and influence solution decisions.
• Experience implementing AI/GenAI, intelligent content automation, regulatory technology, or comparable emerging technology solutions strongly preferred.
