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Senior Product Lead: Generative AI Regulated Documents

Job in Jersey City, Hudson County, New Jersey, 07390, USA
Listing for: BioSpace
Full Time position
Listed on 2026-06-26
Job specializations:
  • IT/Tech
    AI Engineer (Applied/Software)
Job Description & How to Apply Below
Position: Senior Product Lead: Generative AI for Regulated Documents

Global Development IT is seeking a strategic, hands‑on Senior Manager to serve as Product Lead for Regenerons enterprise generative-AI document-authoring platform.

You will be responsible for a multi-phase implementation that delivers governed, scalable AI capabilities across Clinical, Regulatory, Medical Affairs, Labeling, and other Global Development domains. Partnering with business and technology stakeholders, you will align platform strategy to scientific, regulatory, and operational needs, ensuring secure, compliant, and high-impact outcomes.

Reporting to the Head of Enabling Technologies, you will drive the full product lifecycle from vision and roadmap through design, build, validation, launch, and optimization. Your blend of clinical‑process know‑how, agile product leadership, and deep AI expertise will accelerate content creation, improve quality, and reduce cycle times for regulated documents.

In this role, a typical day might include the following:
  • Leading stand‑ups, refining backlogs, and approving user stories for AI‑powered authoring features
  • Facilitating workshops with Clinical, Regulatory, and Medical Affairs teams to gather requirements and prioritize enhancements
  • Reviewing solution architecture to enforce security, privacy, and GxP compliance across RAG, MCP, LLM, Copilot, and Claude integrations
  • Tracking sprint progress, surfacing risks, and updating program leadership on scope, budget, and ROI
  • Defining guardrails for citizen development and coordinating change‑control / governance forums
  • Monitoring platform adoption and performance to identify automation and continuous‑improvement opportunities
This Job Might Be For You If You
  • Translate sophisticated Global Development document workflows into intuitive, AI‑enabled products
  • Excel at influencing cross‑functional teams without direct authority and communicating clearly with executive stakeholders
  • Thrive in agile environments, balancing tactical delivery with long‑term platform strategy
  • Enjoy partnering with data‑science teams to embed generative AI into regulated processes
  • Keep current on industry standard processes and proactively incorporate them into product roadmaps
  • Maintain a get‑it‑done attitude and balance multiple high‑priority initiatives simultaneously
In order to be considered for this role, you must have:
  • BS/BA with 810 years validated experience (or MS/MBA with 6+ years as an equivalent), including 3 years in enterprise SaaS and 1+ year delivering generative/agentic-AI solutions
  • Proven success leading end‑to‑end GxP implementations of AI document‑authoring platforms, using agile/Dev Ops methods
  • Validated expertise in RAG, MCP, LLMs, Copilot, Claude, and integration across Clinical, Regulatory, and Medical Affairs systems

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

For additional information about Regeneron benefits in the US, please visit  For other countries specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regenerons on‑site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status,…

Position Requirements
10+ Years work experience
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