Senior AI Platform Lead – Regulated Document Authoring

BioSpace; New Jersey; On-site; USD 134,000 - 219,000; Full time

Job summary

Regeneron is seeking a Senior Product Manager to lead our enterprise generative‑AI document‑authoring platform, driving the full lifecycle from vision to launch. You will partner with Clinical, Regulatory, and Medical Affairs to deliver governed AI capabilities that accelerate content creation and ensure regulatory compliance.

Reporting to the Associate Director of Product Management in Enabling Technologies, you will manage multi‑phase implementations, balance strategic platform direction with

Qualifications

• BS/BA with 8–10 years validated experience (or MS/MBA with 6+ years), including 3 years in enterprise SaaS and 1+ year delivering generative/agentic‑AI solutions.
• Shown success leading end-to-end GxP implementations of AI document‑authoring platforms, using agile/DevOps methods.
• Validated expertise in RAG, MCP, LLMs, Copilot, Claude, and integration across Clinical, Regulatory, and Medical Affairs systems.

Responsibilities

• Lead stand‑ups, refine backlogs, and approve user stories for AI‑powered authoring features.
• Facilitate workshops with Clinical, Regulatory, and Medical Affairs teams to gather requirements and prioritize enhancements.
• Review solution architecture to enforce security, privacy, and GxP compliance across RAG, MCP, LLM, Copilot, and Claude integrations.
• Track sprint progress, surface risks, and update program leadership on scope, budget, and ROI.
• Define guardrails for citizen development and coordinate change‑control / governance forums.
• Monitor platform adoption and performance to identify automation and continuous‑improvement opportunities.

Skills

Strategic product management

AI experience

Agile methodologies

Cross-functional leadership

Regulatory/compliance

Education

BS/BA with 8-10 years validated experience

Tools

RAG

LLM

Copilot

Claude

Job description

Regeneron is seeking a Senior Product Manager to lead our enterprise generative‑AI document‑authoring platform, driving the full lifecycle from vision to launch. You will partner with Clinical, Regulatory, and Medical Affairs to deliver governed AI capabilities that accelerate content creation and ensure regulatory compliance.

Reporting to the Associate Director of Product Management in Enabling Technologies, you will manage multi‑phase implementations, balance strategic platform direction with