VP, Product Development Regulatory Innovation & Sustainment

Genentech • Daly City, CA

95d • $306,800 - $402,675

About The Position

This is a unique executive leadership opportunity for a visionary pioneer who sees regulation not as a hurdle, but as a dynamic ecosystem ripe for strategic and technological advancement. You will be the primary business architect defining the future of regulatory system solutions for Product Development Regulatory (PDR) within Roche. In collaboration with the Regulatory Portfolio and Data Senior Leaders, you will define the strategic business roadmap for technology-centric solutions, ensuring PDR's capabilities are future-proofed and robustly aligned with our PDR Moonshots and True North goals. Your leadership will bridge business strategy with technological execution, serving as the essential business voice for requirements, strategic direction, and successful adoption of innovative solutions, working in close partnership with the Roche Digital Technology Group (DTG).

Requirements

• 15+ years of relevant experience, including a minimum of 12 years supporting cross-functional teams in a scientific and regulated environment.
• Proven track record of demonstrated leadership in technology, systems, and automation, with specific application to drug development in a regulated environment.
• Expert knowledge of pharmaceutical and device regulatory affairs with a proven ability to influence and navigate the broader business strategy.
• Extensive experience leading a Chapter/Function, encompassing budget oversight, resource allocation, and vendor strategy.
• Experience in managing and interacting with internal and external cross-functional stakeholders to advance complex technology topics.
• PhD or relevant advanced degree preferred.
• Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and mastery of complexity.
• Focuses on delivery through collaboration, breaking down silos, and bringing people together to work towards the same purpose across organizational boundaries.
• Demonstrated success in attracting, developing, and scaling high-performing, globally distributed teams.
• Role model and lead according to VACC (Visionary, Architect, Coach, Catalyst) principles.
• Recognized internally and/or externally as an authority and thought leader, able to influence change within the industry and deliver significant organizational results.

Responsibilities

• Act as the chief business architect, defining the strategic business roadmap for future regulatory system solutions and driving their successful adoption and optimization across PDR and Roche.
• Provide executive leadership in contextualizing and interpreting internal and external system and technology advancements to ensure PDR’s capabilities, skill sets, and strategic investments are optimally aligned with regulatory deliverables.
• Serve as a pivotal senior business leader on the PDR Leadership Team, ensuring sound financial stewardship and co-creating the long-term PDR vision and strategy.
• Drive and influence enterprise-wide strategic initiatives by leveraging a deep understanding of organizational strategy and operations.
• Serve as the Chapter Head for the Innovation & Sustainment Chapter, overseeing operational excellence and ensuring the successful delivery of essential systems and technology solutions.
• Develop Chapter strategy and capabilities while advancing the skills and expertise of the organization to meet future challenges, ensuring a robust succession plan.
• Serve as the global escalation point for resolving the most complex and critical issues related to regulatory systems and processes.
• Act as a senior advisor/consultant to any member of PDR or the wider organization, building partnerships with senior stakeholders to meet strategic business goals.
• Accountable for building working relationships and collaborating with key Health Authorities, industry associations, and other external stakeholders on strategic and policy matters.

Benefits

• Relocation assistance is being offered.
• Discretionary annual bonus may be available based on individual and Company performance.
• Participation in a long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees