Sr Director, Regulatory Data and Content, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

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 position shapes regulatory data and content management across its lifecycle and establishes foundations for advanced 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 useful for current operations and future capabilities. The role also serves as a senior advisor to CMC Regulatory Affairs leadership, leads and develops a mixed workforce responsible for master data management, data stewardship, and regulatory data operations, and builds partnerships across internal functions. It may represent Gilead in external industry consortia, standards organizations, and regulatory forums related to regulatory data and content.

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 requirements and establish integrated regulatory 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.
Experience with regulatory technology ecosystems and platforms such as Veeva Vault RIM or comparable regulatory information and content management technologies.
Understanding of modern data architecture, interoperability, structured content, automation, analytics, and artificial intelligence in regulated business processes.
Experience establishing data and content foundations that enable 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.
Strategic thinking and ability to translate regulatory and technology trends into 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.

Nice To Haves

Advanced degree(s) in a scientific field.
Experience spanning both Clinical and CMC Regulatory Affairs domains.
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 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, and make commitments on behalf of the function.
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.
Advance structured and componentized content, metadata, taxonomy, content reuse, and evolving regulatory authoring and submission approaches.
Establish trusted, governed, interoperable data and content foundations for digital capabilities, analytics, automation, and AI.
Lead the strategy for making regulatory information AI-ready, including appropriate structure, metadata, provenance, traceability, reuse, interoperability, and controls.
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 ensure regulatory data is accessible, trustworthy, and fit for analytics, reporting, and decision-making.
Advise CMC Regulatory Affairs leadership on regulatory data, content, governance, information management, and emerging information capabilities.
Lead and develop employees and teams responsible for master data management, data stewardship, and regulatory data operations.
Establish 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.
Build partnerships across Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, IT, and other PDM functions.
Influence senior stakeholders 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, and bring external developments and leading practices into the organization.
Create inclusion, develop talent, and empower teams by modeling inclusive leadership, coaching employees, aligning team goals, and removing barriers.

Benefits

May be eligible for a discretionary annual bonus.
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.

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