Senior Business Analyst, AI-Driven Regulatory Authoring

Verista, Inc.; Cambridge (MA); On-site; USD 90,000 - 136,000; Full time

Benefits offered by this job

Competitive pay

Life, Short-Term, and Long-Term DI

Health Savings Account

Paid Time Off

Tuition Reimbursement

Team Social Activities

Employee Referral Program

Job summary

Verista, Inc. is seeking an experienced Senior Business Analyst to support AI-enabled regulatory authoring for NDA/BLA submissions in Cambridge, MA.

The role bridges Regulatory CMC teams, IT, and AI/Data groups to translate scientific processes into tech requirements and drive end-to-end SDLC activities. The candidate will lead the analysis for AI-assisted content generation, define use cases for GenAI, build user stories, and ensure validation and traceability.

Qualifications

• 7+ years of experience as a business analyst delivering pharmaceutical technology solutions through a formal IT SDLC.
• Experience with Agile, Jira, and Confluence.
• Practical understanding of CMC regulatory documentation and CTD/eCTD Module 3.
• Must be on-site in Cambridge, MA 3 days/week.
• Experience implementing AI/GenAI, intelligent content automation, regulatory technology, or related solutions is preferred.

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 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, and content reuse
• Develop user stories, acceptance criteria, process flows, UAT scenarios, and requirements traceability
• Define and execute business acceptance criteria for AI-generated CMC content
• Support pharmaceutical IT validation/assurance, deployment readiness, go-live, and post-implementation stabilization

Skills

Business analysis

Agile methodologies

Jira

Confluence

Regulatory knowledge

AI/GenAI awareness

Stakeholder management

Education

Bachelor's degree in Life Sciences/CS

Job description

Verista, Inc. is seeking an experienced Senior Business Analyst to support AI-enabled regulatory authoring for NDA/BLA submissions in Cambridge, MA.

The role bridges Regulatory CMC teams, IT, and AI/Data groups to translate scientific processes into tech requirements and drive end-to-end SDLC activities. The candidate will lead the analysis for AI-assisted content generation, define use cases for GenAI, build user stories, and ensure validation and traceability.