Regulatory Innovation & Sustainment Leader

Posted 7 Days Ago
Be an Early Applicant
4 Locations
In-Office
Entry level
Healthtech • Biotech
The Role
Leads digital transformation of pharmaceutical regulatory workflows through AI and data strategy. Drives cross-functional initiatives, process redesign, innovation, compliance, stakeholder engagement, and enterprise change. Serves as a subject matter expert, mentors colleagues, builds organizational capabilities, and manages complex projects involving internal teams, health authorities, government entities, and external stakeholders.
Summary Generated by Built In

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.

Skills Required

  • Deep knowledge of process redesign for AI and data management practices aligned with business strategy
  • Relevant work experience supporting cross-functional teams in a scientific environment
  • Ability to apply systems thinking and an enterprise-wide mindset to lead change in a matrixed organization
  • Strong commitment to medical compliance, integrity, and the Roche Group Code of Conduct
  • Expert-level ownership of complex, high-impact deliverables
  • Ability to influence and negotiate with global stakeholders and external entities
  • Technical depth, practical expertise, and leadership maturity
  • Continuous learning, collaboration, mentoring, and team capability-building skills

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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