Sr Director, Regulatory Data and Content, Regulatory Affairs CMC

• Serve as the data domain leader for CMC Regulatory Affairs , accountable for regulatory data strategy, definitions, standards, governance, quality expectations, master data management, and stewardship.

• Establish and lead the CMC Regulatory Affairs data governance model, including ownership, decision rights, stewardship, quality standards, and escalation mechanisms for critical regulatory data.

• Represent CMC Regulatory Affairs in PDM and enterprise data and content governance, with authority to establish regulatory positions, negotiate standards, make commitments on behalf of the function, and ensure enterprise approaches meet regulatory needs.

• Partner with Clinical Regulatory Affairs and other functions to drive alignment of regulatory data definitions, standards, governance, and information models.

• Assess the impact of new and evolving health authority expectations for structured data and content and translate those developments into internal data, content, governance, and capability requirements.

• Define and advance CMC Regulatory Affairs content management strategy and standards across the regulatory lifecycle, enabling effective creation, management, traceability, reuse, and maintenance of regulatory information.

• Partner with regulatory content owners and Digital Enablement to advance structured and componentized content, metadata, taxonomy, content reuse, and evolving approaches to regulatory authoring and submission.

• Ensure data and content strategies evolve as an integrated regulatory information ecosystem supporting both human and machine consumption.

• Ensure data and content strategies evolve as an integrated regulatory information ecosystem supporting both human and machine consumption.

• Establish the trusted, governed, and interoperable data and content foundations required for digital capabilities, analytics, automation, and artificial intelligence.

• Lead the strategy to make regulatory information AI-ready, including appropriate structure, metadata, provenance, traceability, reuse, interoperability, and controls.

• Serve as a key business subject matter expert for regulatory information systems and platforms while maintaining clear separation between data/content domain ownership and digital platform or system ownership.

• Provide regulatory data and content expertise in the design and implementation of digital solutions, including RIM, content management, data platforms, workflow technologies, automation, and AI-enabled capabilities.

• Partner with Digital Enablement and Regulatory Operations to ensure digital products, systems, workflows, and automation leverage authoritative regulatory information and established standards.

• Partner with Portfolio Insights & Analytics to ensure regulatory data are accessible, trustworthy, and fit for analytics, reporting, and organizational decision-making.

• Serve as a senior advisor to CMC Regulatory Affairs leadership on regulatory data, content, governance, information management, and emerging information capabilities.

• Lead and develop a mixed workforce responsible for master data management, data stewardship, and regulatory data operations, ensuring critical regulatory data remain under appropriate internal ownership and accountability.

• Establish clear roles, responsibilities, service expectations, and performance measures across data management and stewardship activities.

• Build organizational capability in data ownership, stewardship, data quality, content lifecycle management, and effective use of regulatory information.

• Partner closely with Digital Enablement, Regulatory Operations & Digital Enablement, and Portfolio Insights & Analytics to create an integrated operating model connecting trusted information, effective processes, enabling technology, and actionable insights.

• Build strong partnerships across Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, IT, and other PDM functions to ensure regulatory information requirements are incorporated into broader enterprise data and content strategies.

• Influence senior stakeholders across functional and organizational boundaries and drive resolution of complex data and content issues where ownership, standards, or business requirements intersect.

• Represent Gilead, as appropriate, in external industry consortia, standards organizations, and regulatory forums related to regulatory data, content, information management, and digital regulatory evolution.

• Bring external developments and leading practices into the organization and influence internal and industry approaches where appropriate.

• Bachelor's Degree and 14 years’ experience OR
• Masters' Degree and 12 years’ experience OR
• PhD and 12 years’ experience

• 14+ Years with BA/ BS; 12+ Years with MA/ MS/ MBA/ PharmD/ PhD; Advanced Degree(s) in a scientific field is preferred

• Extensive experience in the pharmaceutical or biotechnology industry, with significant experience in Regulatory Affairs, regulatory operations, regulatory information management, data management, or related functions.

• Demonstrated leadership of enterprise or functional data domains, including experience establishing data governance, data standards, business definitions, stewardship models, and data quality frameworks.

• Strong understanding of CMC Regulatory Affairs and the regulatory lifecycle, including development, registration, post-approval change management, and lifecycle maintenance.

• Deep understanding of the distinct and interdependent needs of Clinical and CMC Regulatory Affairs, with demonstrated ability to navigate differing data, content, process, and lifecycle requirements and establish integrated regulatory approaches. Experience spanning both regulatory domains strongly preferred.

• Deep knowledge of regulatory information and data standards, including relevant experience with ISO IDMP, SPOR, eCTD and structured submission standards, ICH standards, controlled vocabularies, and regulatory information models.

• Demonstrated experience with regulatory information management, document/content management, master data management, metadata, taxonomy, and data lifecycle management.

• Experience with regulatory technology ecosystems and platforms such as Veeva Vault RIM or comparable regulatory information and content management technologies.

• Demonstrated understanding of modern data architecture, interoperability, structured content, automation, analytics, and artificial intelligence and their application within regulated business processes.

• Experience establishing data and content foundations that enable analytics, automation, AI, or other advanced digital capabilities.

• Demonstrated ability to operate as a senior domain leader, establish functional positions, make decisions in complex cross-functional environments, and influence enterprise standards and priorities.

• Experience leading and developing employees, contractors, and/or data stewardship organizations within a global matrixed environment.

• Strong strategic thinking with demonstrated ability to translate future regulatory and technology trends into practical organizational strategies, standards, capabilities, and implementation roadmaps.

• Exceptional communication, negotiation, and influencing skills, including the ability to represent Regulatory Affairs in senior cross-functional governance and decision-making forums.

• Experience participating in or representing an organization through external industry groups, standards bodies, or regulatory information initiatives is preferred.

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.