Regulatory Innovation & Sustainment Leader

Genentech; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Genentech in South San Francisco, CA is seeking a Regulatory Innovation & Sustainment Leader to drive the digital transformation of regulatory workflows, focusing on AI and data strategy across PDR. You will bridge business needs with technical execution to enable innovation while ensuring compliance and operational excellence.

The role demands strategic leadership, cross-functional collaboration with Health Authorities and internal partners, mentorship, and the development of scalable

Qualifications

• Experience shaping AI/data strategy in a regulatory context.
• Ability to lead cross-functional teams in a scientific setting.
• Strong commitment to medical compliance and ethics.

Responsibilities

• Strategic Leadership: Shape strategy and lead high-impact, cross-functional project teams to deliver tangible business outcomes.
• Domain Expertise: Serve as a SME in Digital, AI, and Data to drive创新 (note: kept in English as per language).
• Team Empowerment: Cultivate a collaborative team culture where members influence stakeholders and drive results.
• Mentorship & Thought Leadership: Coach junior colleagues to build internal capability.
• Stakeholder Management: Influence cross-functional teams including Health Authorities and external entities.
• Change Management: Champion continuous improvement and innovative leadership principles.
• Capability Building: Mentor colleagues, build talent, and manage complex projects that unlock enterprise-wide benefits.

Skills

AI strategy

Data management

Cross-functional leadership

Job description

The Position

As a Regulatory Innovation & Sustainment Leader in the Pharmaceutical Development Regulatory (PDR) Innovation & Sustainment chapter, you will drive the digital transformation of regulatory workflows, specifically focusing on AI and data strategy. You will bridge the gap between business needs and technical execution, fostering a culture of innovation while ensuring operational excellence and compliance.

In PDR we develop and maintain our licenses - we influence Health Authorities in their thought process to develop regulations.

The Opportunity:

• Strategic Leadership: Shape strategy and lead high-impact, complex, cross-functional project teams to deliver tangible business outcomes.
• Domain Expertise: Serve as a recognized subject matter expert in Digital, AI, and Data, leveraging a broad cross-discipline skill set to drive innovation.
• Team Empowerment: Cultivate a collaborative team culture where members are empowered to influence stakeholders and drive results.
• Mentorship & Thought Leadership: Act as a go-to thought leader within PDR, coaching and upskilling junior colleagues to build internal capability.
• Stakeholder Management: Influence cross-functional teams, including Health Authorities, government entities, politicians for key topics related to regulatory science and solution & sustainment. Has established networks and utilizes networks with stakeholders external to Roche.
• Change Management: Champion a culture of continuous improvement, experimentation, and VACC (Visionary, Architect, Coach, Catalyst) leadership principles.
• Capability Building: Mentor colleagues, build talent, and manage complex, high-impact projects that unlock enterprise-wide benefits.

Who You Are:

• Deep knowledge of process redesign for AI, data management practices with overarching business strategy to drive innovation.
• Proven relevant work experience which includes supporting cross-functional teams in a scientific environment .
• Proven ability to apply system thinking and an enterprise-wide mindset to lead change within a matrixed organisation.
• Maintain a strong commitment to medical compliance, integrity, and the Roche Group Code of Conduct.
• Expert-level ownership of complex, high-impact deliverables. Operates with distributed authority and accountability. Makes pragmatic, fit-for-purpose decisions, defaults to working transparently, and actively seeks advice to iterate and experiment.
• Employs a continuous learning mindset and actively acts on feedback. Fosters community by prioritizing personal growth, teamwork, and self autonomy
• Measurable reach and strategic results across the organization. Drives outcome-oriented results through strategic agility. Build, share, and leverage interconnected networks to exchange knowledge and advance key insights.
• Demonstrated ability to influence and negotiate with global stakeholders and external entities by communicating transparently, listening actively and building mutual trust. Collaborates through iterative feedback while recognizing and elevating peer contributions.
• Technical depth, practical expertise, and leadership maturity.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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