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Medical Regulatory Lead

Hippocratic AI· G&A
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Menlo Park, CAFull-timePosted 9mo ago

About the role

Head of Regulatory responsible for ensuring Hippocratic AI's life sciences platform meets scientific, medical, and regulatory standards across geographies, guiding regulatory review, compliance, and medical affairs workflows in product, customer deployments, and external stakeholder interactions.

Responsibilities

  • Define and maintain Regulatory standards that govern the platform's patient-facing and HCP-facing interactions.
  • Establish labelling operations frameworks for 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.
  • 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.
  • Partner with legal and compliance teams to ensure platform workflows meet HIPAA, GDPR, and industry-specific data governance standards.
  • Provide medical and regulatory credibility during enterprise sales conversations, RFP responses, and executive workshops with pharma customers.
  • Help Sales navigate MLR, pharmacovigilance, legal, compliance, and governance review processes within prospective and existing accounts.
  • Develop materials and frameworks that demonstrate the platform's regulatory readiness, safety architecture, and medical rigor to customer stakeholders.
  • Offer strategic oversight during early deployments to ensure medical accuracy, safety protocols, and compliance guardrails are properly configured and validated.
  • Translate learnings from customer engagements and pilot deployments into repeatable regulatory and medical affairs playbooks.
  • Develop and publish thought leadership on AI in pharma commercialization — including perspectives on commercial model transformation, patient services evolution, and the strategic implications of agentic AI for pharma operating models.
  • Build internal knowledge bases covering AE reporting workflows, MLR requirements, non-promotional standards, and therapeutic areas–specific regulatory considerations.
  • Identify emerging regulatory trends in AI-enabled healthcare and patient engagement, and advise leadership on their implications for product and go-to-market strategy.

Qualifications

  • 7–15 years of experience in regulatory operations regulatory affairs, within pharma, biotech, or life sciences services organizations.
  • Deep working knowledge of MLR review processes, non-promotional communication standards, and medical information operations and adverse event reporting, pharmacovigilance regulations,
  • Strong understanding of FDA and EMA regulatory frameworks as they apply to patient engagement, medical communications, and digital health technologies.
  • Demonstrated ability to engage credibly with VP, SVP, and C-suite stakeholders across medical, regulatory, legal, and compliance functions at pharma organizations.
  • Experience translating regulatory and medical requirements into operational workflows, product requirements, or technology specifications.
  • Comfort working in high-growth environments with limited structure and high expectations for ownership and cross-functional collaboration.
  • Exceptional written and verbal communication skills.

Skills

Required:Regulatory strategyMLR (Medical, Legal, Regulatory) processesFDA/EMA regulatory frameworksRegulatory communications with executives

Benefits

  • Not explicitly listed in the description.
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hippocratic AI

Safest Healthcare Generative AI Agents

Safest Healthcare Generative AI Agents Our AI agents do not diagnose or prescribe. Learn more. Listen to these 4 real de-identified calls from the over 115 million clinical interactions.

HealthcareAIGenerative AIClinical InteractionsPatient Care
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