Sr Director, Regulatory Data and Content, Regulatory Affairs CMC

Gilead Sciences • Foster City, CA

8d • $243,100 - $314,600

About The Position

Gilead is seeking a Senior Director, Regulatory Data & Content to serve as the data domain leader for CMC Regulatory Affairs. The role establishes the strategy, governance, standards, and capabilities needed to manage regulatory data and content as critical enterprise assets. It is accountable for CMC Regulatory Affairs data definitions and standards, data quality expectations, master data management, stewardship, and governance. The Senior Director represents CMC Regulatory Affairs in PDM-level and cross-enterprise data and content initiatives, establishes regulatory positions, makes decisions on behalf of the function, and ensures enterprise approaches meet regulatory business and compliance needs.

The role shapes regulatory data and content management across the lifecycle and establishes foundations for analytics, automation, artificial intelligence, and increasingly structured, data-driven regulatory interactions. Working with Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, Regulatory Affairs, IT, and other PDM functions, the Senior Director ensures regulatory information is trusted, governed, interoperable, traceable, reusable, and suited to current operations and future capabilities.

The position also provides senior advice to CMC Regulatory Affairs leaders and leads and develops a mixed workforce responsible for master data management, data stewardship, and regulatory data operations. It builds partnerships across internal functions and represents Gilead in relevant external industry groups, standards organizations, and regulatory forums as appropriate.

Requirements

• Bachelor's degree and 14 years of experience, or a master's degree and 12 years of experience, or a PhD and 12 years of experience.
• Extensive pharmaceutical or biotechnology industry experience, 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 establishing data governance, 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 and ability to navigate differing data, content, process, and lifecycle requirements and establish integrated approaches.
• 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.
• Demonstrated understanding of modern data architecture, interoperability, structured content, automation, analytics, and artificial intelligence in regulated business processes.
• Experience establishing data and content foundations for analytics, automation, AI, or other advanced digital capabilities.
• 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 and ability to translate regulatory and technology trends into practical organizational strategies, standards, capabilities, and implementation roadmaps.
• Exceptional communication, negotiation, and influencing skills, including ability to represent Regulatory Affairs in senior cross-functional governance and decision-making forums.

Nice To Haves

• An advanced degree in a scientific field.
• Experience spanning both Clinical and CMC Regulatory Affairs.
• Experience with regulatory technology ecosystems and platforms such as Veeva Vault RIM or comparable regulatory information and content management technologies.
• Experience participating in or representing an organization through external industry groups, standards bodies, or regulatory information initiatives.

Responsibilities

• Serve as the CMC Regulatory Affairs data domain leader, 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.
• Represent CMC Regulatory Affairs in PDM and enterprise data and content governance; 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 align regulatory data definitions, standards, governance, and information models.
• Assess evolving health authority expectations for structured data and content and translate them into internal requirements.
• Define and advance CMC Regulatory Affairs content management strategy and standards across the regulatory lifecycle.
• Partner with regulatory content owners and Digital Enablement to advance structured and componentized content, metadata, taxonomy, content reuse, and regulatory authoring and submission approaches.
• Integrate data and content strategies into a regulatory information ecosystem that supports human and machine consumption.
• Establish trusted, governed, interoperable data and content foundations for digital capabilities, analytics, automation, and artificial intelligence.
• Lead the strategy for making regulatory information AI-ready, including structure, metadata, provenance, traceability, reuse, interoperability, and controls.
• Serve as a business subject matter expert for regulatory information systems and platforms while maintaining 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 use authoritative regulatory information and established standards.
• Partner with Portfolio Insights & Analytics to make regulatory data accessible, trustworthy, and suitable for analytics, reporting, and organizational decision-making.
• Advise 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, maintaining appropriate internal ownership and accountability for critical regulatory data.
• Establish roles, responsibilities, service expectations, and performance measures for data management and stewardship activities.
• Build organizational capability in data ownership, stewardship, data quality, content lifecycle management, and effective use of regulatory information.
• Partner with Digital Enablement, Regulatory Operations & Digital Enablement, and Portfolio Insights & Analytics to create an integrated operating model connecting trusted information, processes, technology, and insights.
• Build partnerships across Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, IT, and other PDM functions to incorporate regulatory information requirements into enterprise data and content strategies.
• Influence senior stakeholders across functions and organizations and resolve complex data and content issues involving intersecting ownership, standards, or business requirements.
• 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.
• Create inclusion, develop talent, and empower teams by modeling inclusive leadership, coaching employees, aligning team goals with organizational objectives, and helping remove barriers.

Benefits

• The position may be eligible for a discretionary annual bonus.
• The position may be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior