Senior Product Manager, AI Regulated Document Platform

Initial Therapeutics, Inc.; New Jersey; On-site; USD 134,400 - 219,200; Full time

Job summary

Regeneron is seeking a strategic, hands-on Senior Product Manager to lead an enterprise generative-AI document-authoring platform across Clinical, Regulatory, Medical Affairs, Labeling, and other domains. You’ll drive the full lifecycle from vision to optimization, aligning with scientific and regulatory needs while ensuring security and compliance.

You will work with business and technology stakeholders, partnering to accelerate content creation, improve quality, and reduce cycle times for

Qualifications

• 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.
• Collaborate with data-science teams to embed generative AI into regulated processes.
• Keep current on industry standard processes and proactively incorporate them into product roadmaps.
• Balance multiple high-priority initiatives with a get-it-done attitude.

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.
• Review solution architecture for security, privacy, and GxP compliance across integrations.
• Track sprint progress, surface risks, and update leadership on scope, budget, ROI.
• Define guardrails for citizen development and coordinate governance forums.
• Monitor platform adoption and identify automation opportunities.

Skills

AI product management

Agile leadership

Stakeholder communication

Cross-functional collaboration

Regulatory domain understanding

Education

BS/BA with 8-10 years experience

Tools

RAG/MCP/LLMs

Copilot

Claude

Job description

Regeneron is seeking a strategic, hands-on Senior Product Manager to lead an enterprise generative-AI document-authoring platform across Clinical, Regulatory, Medical Affairs, Labeling, and other domains. You’ll drive the full lifecycle from vision to optimization, aligning with scientific and regulatory needs while ensuring security and compliance.

You will work with business and technology stakeholders, partnering to accelerate content creation, improve quality, and reduce cycle times for