Regulatory Innovation & Sustainment Leader

F. Hoffmann-La Roche AG

Welwyn Hatfield

On-site

GBP 90,000 - 150,000

Full time

12 days ago
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Job summary

Genentech is seeking a Regulatory Innovation & Sustainment Leader to drive digital transformation of regulatory workflows with a focus on AI and data strategy. You will bridge business needs with technical execution, mentoring teams and influencing Health Authorities to advance regulatory science.

In this senior role, you will shape strategy, lead cross-functional initiatives, and foster a culture of innovation while ensuring compliance and operational excellence within the Roche Group.

Qualifications

  • Deep knowledge of AI and data strategy within regulatory/scientific contexts.
  • Proven experience leading cross-functional teams on complex projects.
  • Ability to influence global stakeholders and manage regulatory programs.
  • Commitment to medical compliance and Roche Code of Conduct.
  • Strong change-management and leadership capabilities.

Responsibilities

  • Shape strategy and lead high-impact, cross-functional programs to deliver business outcomes.
  • Mentor colleagues, upskill teams, and foster internal capability in PDR.
  • Drive stakeholder management across Health Authorities and external entities.
  • Champion continuous improvement and an enterprise-wide mindset.

Skills

AI strategy
Data management
Cross-functional leadership
Change management
Stakeholder management
Regulatory collaboration

Job description

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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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