Global Head Regulatory Data, Digital and AI

Roche•South San Francisco, CA

10d

About The Position

The PTR Data, Digital and AI team drives the technological transformation of our regulatory domain to accelerate the delivery of novel therapeutics to patients worldwide. By leveraging cutting-edge automation, data analytics, and artificial intelligence, we streamline regulatory submissions and processes and empower our global network to operate with agility and precision.

Requirements

University degree (Master's or PhD preferred) in Data Science, Computer Science, Engineering, Life Sciences, or a related technical discipline.
Extensive experience in the pharmaceutical or biotechnology industry with a strong focus on digital transformation, technology implementation, and advanced analytics.
Deep expertise in enterprise data governance, AI governance, master data management, and building business intelligence platforms.
Proven background in establishing cross-functional change management, senior stakeholder alignment, and leading end-to-end operational improvements.
Leadership experience in coaching, mentoring, and developing high-performing teams in an agile setting.

Nice To Haves

A good understanding of regulatory affairs would also be beneficial.
Experience in pharmaceutical regulatory affairs operations is a distinct advantage.

Responsibilities

Lead the definition, ownership, and execution of the digital, automation, and AI strategy across Technical Regulatory.
Translate strategic visions into actionable tactical execution plans with defined milestones, clear ownership, and measurable business impact.
Evaluate, architect, and deploy innovative digital solutions, including generative AI, machine learning, and routine workflow automation.
Establish robust data governance and AI governance frameworks to ensure compliant, high-quality data stewardship across the ecosystem.
Partner with IT, RIM Business Owners, Data Stewards, and technology vendors to drive end-to-end delivery of digital capabilities.
Build advanced analytics, business intelligence, and real-time performance dashboards to track organizational effectiveness.
Champion change-management plans, process optimization, and training curricula to ensure broad adoption of new digital tools.
Represent department needs in senior leadership and governance forums while actively engaging with external industry networks and regulatory bodies.
Lead, mentor, and empower a high-performing team of strategic digital leads while managing portfolio priorities and resource allocation.