Regulatory Innovation & Sustainment Leader

Roche; South San Francisco (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Roche in Welwyn is seeking a Regulatory Innovation & Sustainment Leader to drive the digital transformation of regulatory workflows, with a focus on AI and data strategy. You will bridge business needs and technical execution while upholding compliance and operational excellence.

In this senior role you will lead cross-functional teams, mentor colleagues, influence Health Authorities and external stakeholders, and shape strategy for the PDR Innovation & Sustainment chapter, delivering measurable

Qualifications

• Deep knowledge of AI-driven process redesign and data management aligned with business strategy.
• Experience supporting cross-functional teams in a scientific environment.
• Ability to apply system thinking and lead change in a matrixed organisation.

Responsibilities

• Shape strategy and lead cross-functional project teams to deliver regulatory innovations.
• Serve as a subject matter expert in Digital, AI, and Data to drive innovation.
• Mentor colleagues and build internal capability across PDR.

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.