Director, Regulatory

Hippocratic AI•Menlo Park, CA

About The Position

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.

Requirements

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.

Nice To Haves

Experience with digital health platforms, AI in healthcare, or patient engagement technologies.
Familiarity with HIPAA, GDPR, and data privacy frameworks in the context of patient-facing technology.
Prior experience supporting enterprise sales or technology deployments into large pharma organizations from a medical or regulatory perspective.
MD, PharmD, PhD, or advanced scientific degree strongly preferred. MBA, MPH, or MS also valued.
Startup or early-stage company experience.

Responsibilities

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.
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.