Head, Regulatory Program Management

About the Role

As the Head of Regulatory Program Management, you will serve as a transformational executive leader with 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.

Responsibilities

• Strategic Leadership & Enterprise Advisory
  • Portfolio Regulatory Oversight: 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.
  • Senior Executive Alignment: 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).
  • Enterprise Influence: 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.
  • Financial Stewardship: Hold senior leader financial authority and budget oversight for PDR, ensuring compliant management, resource optimization, and business continuity.
• Chapter Strategy & Talent Pipeline
  • 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.
  • High-Performance Operating Model: Dismantle functional, behavioral, and geographic silos across PDR, role-modeling a OnePDR mindset to foster a unified, highly accountable operating model.
  • Talent Development & Succession: Actively identify and accelerate high-potential talent, building a robust pipeline and actionable succession plan to cultivate the next generation of executive leaders.
• Global Escalation & Health Authority Engagement
  • Global Escalation Authority: Serve as the ultimate escalation point for complex, high-stakes regulatory challenges across portfolio teams.
  • Strategic Health Authority Engagement: Directly shape and lead strategies for critical Health Authority negotiations (e.g., FDA Advisory Committee meetings) and influence broader industry-wide regulatory policy shifts.
• Tech & Innovation Acceleration
  • Partner with Senior Leaders to identify use cases for technology innovation, experimentation, and modern regulatory data integration.
• Leadership & Coaching
  • VACC Leadership: Lead through Visionary, Architect, Coach, and Catalyst (VACC) principles, embedding the Roche Leadership Framework and People Practices.
  • Coaching & Empowerment: Coach direct reports and community members to problem-solve, explore optimal paths forward, and drive impact rather than merely executing activities.

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.
• Leadership & Chapter Management: Demonstrated success leading a large Chapter or Function, including budget oversight, vendor strategy, resource allocation, and capability development across globally distributed teams.
• Technical & Scientific Expertise: Deep expertise in global regulatory affairs, drug development, novel platforms, manufacturing, and device regulations, with a track record of navigating complex corporate-critical activities.
• Executive Presence & Influence: 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).
• Location & Presence: 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.

Preferred Qualifications

• 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).

Benefits

Roche offers a competitive compensation package, comprehensive global benefits, and an extraordinary culture centered on innovation, inclusion, and a shared purpose to improve patient lives.

Pay

The expected salary range for this position based on the primary location of California is $351,050–$433,755 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Schedule

This is a fully on-site role.