Associate Director, Operational and Digital Enablement, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

12d•$182,070 - $235,620

About The Position

Gilead is seeking an Associate Director to advance operational effectiveness and digital enablement across CMC Regulatory Affairs. The role leads and supports business process design and optimization, digital and automation enablement, operational scalability, and implementation of new ways of working. The Associate Director partners across CMC Regulatory Affairs, other PDM functions, Regulatory Affairs, IT, and other stakeholders to translate business needs into practical, sustainable process and digital solutions. The position requires a strong understanding of regulatory operations and demonstrated capability in process improvement, digital technologies, data, and change implementation. The successful candidate will move between business problems, process design, technology-enabled solutions, and implementation to improve global CMC Regulatory Affairs operations. The role also leads complex cross-functional initiatives and organizational change, including stakeholder engagement, communications, training, adoption strategies, and measurement of outcomes. As a people leader, the role is expected to foster inclusion, develop talent, and empower teams.

Requirements

10 or more years of experience with a BS/BA, or 8 or more years with an MS/MA or 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, highly matrixed organization.
Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle.
Ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive work through implementation.
Strong facilitation skills, including gathering subject matter expert input and translating 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.

Nice To Haves

BA/BS in Life Sciences, Engineering, or a related field.
Experience with CMC regulatory processes.
Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.
Experience with Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar enterprise platforms and tools.
Lean, Lean Six Sigma, or other process improvement training or certification; practical application of process improvement methodologies is emphasized.

Responsibilities

Lead business process mapping, analysis, design, and optimization 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 with process owners and subject matter experts.
Use structured problem-solving and data-driven approaches to assess root causes and options and develop practical, sustainable solutions.
Facilitate cross-functional workshops to define current- and future-state processes, clarify roles and decision points, and establish implementation plans.
Support development and maintenance of process standards, procedures, governance mechanisms, and operational controls.
Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and improvement opportunities.
Support portfolio, resource, and operational planning, including use of enterprise planning and resource forecasting tools.
Partner with the CMC Digital Enablement Head, process owners, IT, and stakeholders to identify and advance digital opportunities addressing regulatory business needs.
Translate regulatory operational needs and process requirements into business requirements and use cases for digital, automation, data, and technology solutions.
Lead or support digital solution implementation from business problem definition and requirements through testing, deployment, adoption, and continuous improvement.
Establish and monitor success metrics for digital and AI-enabled capabilities, including adoption, efficiency, quality, user experience, and business value.
Evaluate workflow automation, analytics, artificial intelligence, and emerging technologies to improve regulatory processes and decision-making.
Support integration of regulatory processes, data, content, and systems, and collaborate with data and system owners to improve data quality, usability, and availability.
Develop dashboards, metrics, and operational insights to increase performance visibility and enable data-driven decisions.
Support user acceptance testing, implementation readiness, change management, and adoption of new or enhanced digital capabilities.
Lead complex cross-functional initiatives involving CMC Regulatory Affairs and relevant Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, Strategy & Operations, IT, and other stakeholders.
Define project objectives, scope, deliverables, roles, dependencies, and implementation plans for assigned initiatives.
Build stakeholder alignment across 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 challenges, opportunities, risks, and solutions.
Partner with Regulatory Policy, Intelligence, and Health Authority Strategy colleagues to keep processes and solutions aligned with evolving global regulatory requirements and expectations.
Drive organizational change to implement new processes, digital tools, and AI-enabled ways of working, including stakeholder engagement, communications, training, adoption strategies, and outcome measurement.
Promote effective process management and digital ways of working by sharing tools, methodologies, lessons learned, and scalable approaches.
Model inclusion, support employee development through feedback and coaching, and empower teams by connecting their work to organizational goals and helping remove barriers.