Associate Director, Operational and Digital Enablement, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

10d•$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 initiatives in business process design and optimization, digital and automation enablement, operational scalability, and implementation of new ways of working. It partners across CMC Regulatory Affairs, other PDM functions, Regulatory Affairs, and IT to turn business needs into practical, sustainable process and digital solutions. The position combines regulatory operations knowledge with capabilities in process improvement, digital technologies, data, and change implementation, with a focus on improving global CMC Regulatory Affairs operations. The Associate Director leads operational improvement and digital initiatives from problem definition and process design through implementation, adoption, and continuous improvement. The role works with cross-functional and global stakeholders, develops recommendations and decision materials for leadership, and supports change management for new processes, digital tools, and AI-enabled ways of working. It also carries people-leader accountabilities to foster inclusion, develop talent, and empower teams. The salary range is $182,070 to $235,620. The position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance plans. Actual compensation varies based on factors including experience, qualifications, and geographic location.

Requirements

At least 10 years of experience with a BS/BA, or at least 8 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.
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 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, with relevant industry experience.
Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; CMC regulatory process experience is strongly preferred.
Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.
Experience with enterprise platforms and tools such as Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies.
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 investigate root causes, assess options, and develop practical, sustainable solutions.
Facilitate cross-functional workshops to define current- and future-state processes, roles, decision points, and implementation plans.
Support development and maintenance of process standards, procedures, governance mechanisms, and operational controls.
Develop and monitor operational measures and KPIs to assess 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, business 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 realization.
Evaluate workflow automation, analytics, artificial intelligence, and emerging technologies for improving regulatory processes and decision-making.
Support integration of regulatory processes, data, content, and systems to enable 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 to improve performance visibility and support 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, Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, Strategy & Operations, IT, and other stakeholders.
Establish 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 operational challenges, opportunities, risks, and potential 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 initiatives for new processes, digital tools, and AI-enabled ways of working, including stakeholder engagement, communications, training, adoption strategies, and outcome measurement.
Promote process management and digital ways of working by sharing tools, methodologies, lessons learned, and scalable approaches.
Model inclusion and embed the value of diversity in how teams are supported and led.
Support employee development through feedback, coaching, and insight.
Connect teams to broader organizational goals, remove barriers, and strengthen connections across the organization.