Manager, Regulatory Data and Content, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

7d•$146,540 - $189,640

About The Position

Gilead is seeking a Manager, Regulatory Data and Content, CMC Regulatory Affairs, to support the quality, integrity, and effective management of regulatory data and content throughout the CMC regulatory lifecycle. The role serves as an operational data steward, maintaining critical regulatory data and supporting data quality and governance so information is complete, accurate, consistent, and fit for its intended use. Particularly during the first year, the role includes direct data entry and maintenance, providing a foundation in CMC regulatory processes, data, systems, and information flows. Beyond operational stewardship, the Manager contributes to CMC Regulatory Affairs data and content capabilities through data quality initiatives, process development, governance, system and solution testing, and cross-functional projects. The position participates in emerging PDM-wide data governance structures and partners with CMC Regulatory Affairs, Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, IT, and other PDM functions. It offers an opportunity to develop expertise spanning Regulatory Affairs, data, content, process, and digital capabilities, supporting increasingly structured, connected, and data-driven regulatory operations. The role also carries People Leader accountabilities: creating an inclusive environment, developing talent through feedback and coaching, and empowering teams by connecting their work to organizational goals and helping remove barriers.

Requirements

At least 6 years of experience with a bachelor’s degree, or at least 4 years with a master’s degree.
Experience with Veeva Vault or regulatory information management systems is required.
Ability and willingness to perform detailed operational data stewardship and data maintenance while developing broader expertise in data governance, regulatory processes, and digital capabilities.
Strong attention to detail and commitment to data accuracy and quality.
Strong analytical and problem-solving skills, including identifying patterns, investigating discrepancies, understanding root causes, and recommending practical improvements.
Ability to understand and follow data standards, business rules, procedures, and governance requirements, while recognizing opportunities to improve them.
Strong collaboration and communication skills to work with subject matter experts, process owners, system teams, and cross-functional stakeholders.
Strong organizational skills and ability to manage detailed operational work alongside project assignments and continuous improvement activities.
Curiosity about how data, content, processes, and technology connect, and interest in developing expertise in regulatory data governance, digital capabilities, analytics, automation, and emerging technologies.
People Leader capabilities: create inclusion, develop talent, and empower teams.

Nice To Haves

A degree in life sciences, information or data management, engineering, or computer science.
Relevant experience in the pharmaceutical or biotechnology industry, Regulatory Affairs, data or information management, operations, quality, or another regulated environment.
Previous CMC Regulatory Affairs experience.
Experience with or aptitude for enterprise information systems, databases, document or content management platforms, workflow technologies, or similar digital tools.
Familiarity with data governance, master data management, data quality, metadata, controlled vocabularies, or information lifecycle management.
Experience participating in process design, requirements gathering, system testing, user acceptance testing, or implementation activities.
Knowledge of pharmaceutical development and regulatory processes.

Responsibilities

Serve as an operational data steward for CMC Regulatory Affairs, creating, entering, maintaining, reviewing, and managing critical regulatory data throughout its lifecycle in relevant regulatory and enterprise systems.
Ensure regulatory data are accurate, complete, consistent, and handled according to established data definitions, standards, business rules, and procedures.
Conduct routine and targeted data quality reviews; identify discrepancies and gaps, investigate root causes, and coordinate resolution with data owners, process owners, and system stakeholders.
Develop expertise in CMC Regulatory Affairs data, content, processes, and systems, and serve as a resource on data entry, interpretation, quality, and use.
Support data remediation, reconciliation, migration, and master data management activities.
Support implementation of the CMC Regulatory Affairs data governance framework, including data definitions, standards, quality expectations, stewardship responsibilities, and governance processes.
Represent CMC Regulatory Affairs in PDM-wide data governance forums and working groups, provide regulatory subject matter input, and communicate decisions and requirements to CMC Regulatory Affairs.
Monitor data quality, identify recurring issues and trends, and recommend improvements to upstream processes to prevent data quality problems.
Support development and maintenance of data definitions, business rules, controlled terminology, metadata, data quality measures, and stewardship documentation.
Partner with data owners, stewards, and stakeholders to promote consistent data standards and appropriate management of critical regulatory data.
Contribute data and content expertise to CMC Regulatory Affairs and PDM-wide process, system, digital, and data initiatives.
Review new or revised business processes for data and content requirements, quality risks, and effects on data creation, maintenance, governance, and downstream use.
Support development and documentation of processes, procedures, workflows, business rules, and operational controls related to regulatory data and content.
Participate in requirements development, process reviews, user acceptance testing, data validation, implementation readiness, and post-implementation assessment for new or enhanced systems and digital capabilities.
Partner with Digital Enablement and Regulatory Operations to ensure solutions incorporate regulatory data definitions, standards, quality expectations, and user needs.
Support regulatory content management capabilities, including metadata, taxonomy, traceability, structured content, content reuse, and lifecycle management.
Partner with Portfolio Insights & Analytics to improve completeness, consistency, and usability of regulatory data used for reporting, analytics, and organizational decision-making.
Identify opportunities to simplify manual activities, improve data flows, automate repeatable work, and strengthen data quality through process or technology improvements.
Support development and use of data quality metrics and other measures that show the health and usability of the CMC Regulatory Affairs data domain.
Build knowledge of emerging approaches to regulatory data, structured content, automation, and artificial intelligence, and contribute to making regulatory information more structured, governed, traceable, reusable, and AI-ready.
Create inclusion by modeling inclusion and embedding the value of diversity in how teams are supported and led.
Develop talent by understanding employees’ skills, experiences, aspirations, and potential, and providing feedback, coaching, and insight to support development.
Empower teams by connecting them to broader organizational goals, helping remove barriers, and strengthening connections across the organization.