Head of Regulatory Affairs - Life Sciences AI

Hippocratic AI; Menlo Park (CA); Vor Ort; USD 220.000 - 320.000; Vollzeit

Zusammenfassung

Hippocratic AI is seeking a Head of Regulatory to ensure our life sciences platform meets scientific, medical, and regulatory standards for patient and healthcare professional interactions. You will oversee regulatory review cycles, tracking, and compliance across geographies, guiding MLR processes and labeling strategies while supporting enterprise sales and deployments with clinical credibility.

You will report to senior leadership and collaborate with Product, Engineering, and Legal to embed

Qualifikationen

• Extensive experience in regulatory operations within pharma/biotech/life sciences services.
• Deep knowledge of MLR reviews, non-promotional standards, and pharmacovigilance.
• Understanding FDA/EMA frameworks for patient engagement and digital health.
• Ability to engage with senior executives across medical, regulatory, legal and compliance.
• Experience turning regulatory needs into product or technology requirements.
• Comfort in high-growth, semi-structured environments with ownership expectations.
• Excellent written and verbal communication skills.

Aufgaben

• Define and maintain Regulatory standards for patient and HCP interactions.
• Oversee labeling operations, ensure evidence-based and compliant responses.
• Guide regulatory requirements for medical inquiries, off-label questions, and content.
• Partner with product to architect AI medical guardrails and workflows.
• Support regulatory reviews across FDA/EMA and other jurisdictions in deployments.
• Provide credibility during enterprise sales and deployment conversations.

Kenntnisse

Regulatory affairs

Medical information

FDA/EMA knowledge

Stakeholder engagement

Regulatory workflows

Cross-functional collaboration

Communication skills

Ausbildung

MD/PhD/PharmD

MBA/MPH/MS

Jobbeschreibung

Hippocratic AI is seeking a Head of Regulatory to ensure our life sciences platform meets scientific, medical, and regulatory standards for patient and healthcare professional interactions. You will oversee regulatory review cycles, tracking, and compliance across geographies, guiding MLR processes and labeling strategies while supporting enterprise sales and deployments with clinical credibility.

You will report to senior leadership and collaborate with Product, Engineering, and Legal to embed