Head, Regulatory Program Management

Genentech • Daly City, CA

1d • $351,050 - $433,755 • Onsite

About The Position

As the Head, Regulatory Program Management, you will serve as a transformational executive leader holding dual accountability for Chapter capability development and end-to-end global regulatory execution across the entire Roche Pharmaceuticals portfolio (medicinal products and devices). In this high-visibility, fully on-site role, you will act as a senior business leader and trusted advisor to the Roche enterprise (including the Genentech Executive Committee, US functions, and global Roche leadership). Partnering with the OnePDR Leadership Team, you will contextualize the regulatory landscape, ensure financial stewardship over PDR budgets, architect long-term capability strategies, and lead global Health Authority interactions to advance life-saving medicines for patients worldwide.

Requirements

• Minimum 18 years of relevant experience, including at least 15 years supporting cross-functional teams in a scientific environment with a proven track record of leading global regulatory strategy and execution in a highly regulated industry.
• Demonstrated success leading a large Chapter or Function, including budget oversight, vendor strategy, resource allocation, and capability development across globally distributed teams.
• Deep expertise in global regulatory affairs, drug development, novel platforms, manufacturing, and device regulations, with a track record of navigating complex corporate-critical activities.
• Proven ability to navigate ambiguity, manage complexity, and engage with credibility before C-suite executives, governance bodies, and health authority leadership (e.g., FDA, EMA).
• Ability to maintain a 100% fully on-site presence to serve as a visible, anchoring leader for the local PDR community while seamlessly navigating multiple global time zones.

Nice To Haves

• Direct experience leading high-stakes Health Authority interactions (such as FDA Advisory Committees) and driving external regulatory policy shifts.
• Advanced degree in a scientific, medical, or regulatory discipline (e.g., Ph.D., PharmD, MD, or Master’s in Regulatory Science).

Responsibilities

• Direct end-to-end global regulatory strategy, risk mitigation, and Health Authority interactions across the entire Roche Pharmaceuticals portfolio to meet business priorities and ensure our license to operate.
• Serve as a trusted advisor to senior enterprise stakeholders (including the Genentech Executive Committee, US/Group Functions, PT, and Roche DIA) and health authority leadership (e.g., FDA, EMA/EC).
• Shape and drive enterprise-wide strategic initiatives by leveraging deep organizational knowledge, translating regulatory trends into actionable insights, and serving as a delegate for the Global Head of PDR when appropriate.
• Hold senior leader financial authority and budget oversight for PDR, ensuring compliant management, resource optimization, and business continuity.
• Lead the PD Regulatory Program Management Chapter. Architect long-term investment strategies to build next-generation technical proficiencies, including digital/data science integration and complex device regulatory frameworks.
• Dismantle functional, behavioral, and geographic silos across PDR, role-modeling a OnePDR mindset to foster a unified, highly accountable operating model.
• Actively identify and accelerate high-potential talent, building a robust pipeline and actionable succession plan to cultivate the next generation of executive leaders.
• Serve as the ultimate escalation point for complex, high-stakes regulatory challenges across portfolio teams.
• Directly shape and lead strategies for critical Health Authority negotiations (e.g., FDA Advisory Committee meetings) and influence broader industry-wide regulatory policy shifts.
• Partner with Senior Leaders to identify use cases for technology innovation, experimentation, and modern regulatory data integration.
• Lead through Visionary, Architect, Coach, and Catalyst (VACC) principles, embedding the Roche Leadership Framework and People Practices.
• Coach direct reports and community members to problem-solve, explore optimal paths forward, and drive impact rather than merely executing activities.

Benefits

• Competitive compensation package
• Comprehensive global benefits
• Extraordinary culture centered on innovation, inclusion, and a shared purpose to improve patient lives.
• Opportunity to shape the future of global regulatory science
• Opportunity to mentor exceptional talent
• Opportunity to leave a lasting mark on the global healthcare landscape
• Discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive