Director, Regulatory

Role Summary

The Head of Regulatory is responsible for ensuring Hippocratic AI's life sciences platform meets the scientific, medical, and regulatory standards required to operate within life science environments. You will serve as the company's authoritative voice on Regulatory Review cycle management, regulatory tracking and compliance, regulatory review including non-promotional engagement standards — working at the intersection of product, customer deployments, and external stakeholders.

You will guide how the platform handles MLR review processes, and regulatory requirements across therapeutic areas and geographies. You will also support enterprise sales and deployment conversations where medical credibility and regulatory confidence are critical to closing and scaling accounts.

You will report to the SVP of Medical Affairs, and work closely with the President of Life Sciences, Chief Commercial Officer, Sales, Customer Success, Product, and Engineering leadership.

Key Responsibilities

Regulatory Strategy and Oversight

• Define and maintain Regulatory standards that govern the platform's patient-facing and HCP-facing interactions.

• Establish labelling operations frameworks for l delivery, ensuring responses are accurate, evidence-based, and aligned with approved labeling and non-promotional requirements.

• Advise on the regulatory requirements to ensure platform's compliant handling of medical inquiries, off-label questions, and clinical content across therapeutic areas.

• Creative thinker who brings original ideas to the table and can partner with the product team to architect purpose-built AI agents for medical affairs workflows

• Partner with Product and Engineering to support medical guardrails, escalation pathways, and clinical logic into platform workflows.

• Stay current on therapeutic landscape developments, treatment guidelines, and medical communication best practices relevant to the platform's use cases.

Regulatory and Compliance Guidance

• Own the regulatory strategy for how the platform operates within pharma customer environments, including MLR review processes, adverse event reporting obligations, and privacy requirements.

• Guide internal teams and pharma customers on regulatory requirements across FDA, EMA, and other relevant jurisdictions as they apply to AI-enabled patient and HCP engagement.

• Serve as the primary point of contact for customer medical, safety, legal, and regulatory stakeholders during sales and deployment conversations.