Regulatory AI Capability Lead

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Gilead is seeking an Regulatory AI Capability Lead to advance operational effectiveness and digital enablement across CMC Regulatory Affairs.

This role will lead and support initiatives focused on business process design and optimization, digital and automation enablement, operational scalability, and effective implementation of new ways of working. The Associate Director will partner across CMC Regulatory Affairs, other PDM functions, Regulatory Affairs, and IT to translate business needs into practical, sustainable process and digital solutions.

The role requires a strong understanding of regulatory operations combined with demonstrated capability in process improvement, digital technologies, data, and change implementation. The successful candidate will be comfortable moving between business problems, process design, technology-enabled solutions, and implementation to improve how CMC Regulatory Affairs operates globally.

Key Responsibilities

Regulatory Operations & Process Improvement

• Lead business process mapping, analysis, design, and optimization initiatives across CMC Regulatory Affairs, including development, registration, post-approval, and lifecycle management activities.

• Identify operational pain points, process gaps, inefficiencies, and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.

• Apply structured problem-solving and data-driven approaches to evaluate root causes, assess options, and develop practical and sustainable solutions.

• Facilitate cross-functional workshops and working sessions to define current and future-state processes, clarify roles and decision points, and establish implementation plans.

• Support the development and maintenance of process standards, procedures, governance mechanisms, and operational controls that enable consistent execution across CMC Regulatory Affairs.

• Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and opportunities for continued improvement

• Support portfolio, resource, and operational planning activities as needed, including use of enterprise planning and resource forecasting tools.

Digital Enablement, Data & Systems

• Partner with the CMC Digital Enablement Head, business process owners, IT, and other stakeholders to identify and advance digital opportunities that address meaningful regulatory business needs.

• Translate regulatory operational needs and process requirements into clear business requirements and use cases for digital, automation, data, and technology solutions.

• Lead or support the implementation of digital solutions from business problem definition and requirements development through testing, deployment, adoption, and continuous improvement.

• Establish and monitor success metrics for digital and AI-enabled capabilities including adoption, operational efficiency, quality, user experience, and business value realization.

• Evaluate opportunities to apply workflow automation, analytics, artificial intelligence, and emerging technologies to improve regulatory processes and decision-making.

• Support integration of regulatory processes, data, content, and systems to enable more connected and efficient ways of working.

• Partner with data and system owners to improve data quality, usability, and availability for regulatory operations, analytics, and decision-making.

• Develop dashboards, metrics, and operational insights that increase visibility into performance and enable data-driven decisions.

• Support user acceptance testing, implementation readiness, change management, and adoption of new or enhanced digital capabilities.

Cross-Functional Delivery & Change Leadership

• Lead complex cross-functional initiatives involving CMC Regulatory Affairs, Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, Strategy & Operations, IT, and other relevant stakeholders.

• Establish clear project objectives, scope, deliverables, roles, dependencies, and implementation plans for assigned initiatives.

• Build alignment among stakeholders with differing priorities and translate complex operational or technical topics into clear business decisions and actions.

• Develop recommendations and decision materials for CMC Regulatory Affairs leadership based on analysis of operational challenges, opportunities, risks, and potential solutions.

• Partner with Regulatory Policy, Intelligence, and Health Authority Strategy colleagues to ensure processes and solutions remain aligned with evolving global regulatory requirements and expectations.

• Drive organizational change initiatives to successfully implement new processes, digital tools, and AI-enabled ways of working, including stakeholder engagement, communications, training, adoption strategies and measurement of expected outcomes.

• Promote effective process management and digital ways of working across CMC Regulatory Affairs by sharing tools, methodologies, lessons learned, and scalable approaches.

Qualifications

• BA/BS in Life Sciences, Engineering or related field preferred with relevant industry experience 10+ years with BS/BA; 8+ years with MS/MA/MBA

• Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or a related regulated environment.

• Demonstrated experience leading business process design, mapping, optimization, or operational improvement initiatives.

• Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.

• Experience leading complex, cross-functional initiatives in a global and highly matrixed organization.

• Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; experience with CMC regulatory processes strongly preferred.

• Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.

• Experience with relevant enterprise platforms and tools such as Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies is desirable.

• Demonstrated ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive work through implementation.

• Strong facilitation skills with demonstrated ability to gather subject matter expert input and translate it into clear, practical end-to-end processes and requirements.

• Strong communication and influencing skills with the ability to work effectively across functions and organizational levels.

• Lean, Lean Six Sigma, or other process improvement training or certification is desirable; demonstrated practical application of process improvement methodologies is more important than certification alone.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

The salary range for this position is CAD $158,355 - $204,930 annually. In addition, this role is eligible for a discretionary target annual bonus. Gilead determines base compensation by considering factors such as experience, qualifications, and geographic location. As a result, actual compensation may vary.

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