Manager, Regulatory Data and Content, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

8d•$146,540 - $189,640

About The Position

Gilead is seeking a Manager, Regulatory Data & 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 position includes direct data entry and maintenance, providing a foundation in CMC regulatory processes, data, systems, and information flows. The Manager will also contribute to the development of CMC Regulatory Affairs data and content capabilities through data quality initiatives, process development, governance, system and solution testing, and cross-functional projects. The role 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 the opportunity to build expertise at the intersection of Regulatory Affairs, data, content, process, and digital capabilities, while helping advance more structured, connected, and data-driven regulatory operations. As a people leader, the position is also expected to foster inclusion, develop employee talent, and empower teams by connecting their work to organizational goals and helping remove barriers.

Requirements

6+ years of experience with a BS/BA, or 4+ years of experience with an MS/MA.
Relevant experience in the pharmaceutical or biotechnology industry, Regulatory Affairs, data or information management, operations, quality, or another regulated environment.
Experience with Veeva Vault or regulatory information management systems is required.
Demonstrated interest in working with data and information, strong attention to detail, and commitment to data accuracy and quality.
Ability and willingness to perform detailed operational data stewardship and maintenance while developing expertise in data governance, regulatory processes, and digital capabilities.
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 identifying opportunities to improve them.
Strong collaboration and communication skills and ability to work effectively with subject matter experts, process owners, system teams, and cross-functional stakeholders.
Strong organizational skills and ability to manage detailed operational responsibilities alongside project assignments and continuous improvement activities.
Curiosity about how data, content, processes, and technology connect, with interest in regulatory data governance, digital capabilities, analytics, automation, and emerging technologies.
For people leaders: ability to model inclusion, develop talent through feedback and coaching, and empower teams by connecting them to organizational goals and removing barriers.

Nice To Haves

A degree in Life Sciences, Information/Data Management, Engineering, or Computer Science.
Previous CMC Regulatory Affairs experience.
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 systems.
Ensure regulatory data is accurate, complete, consistent, and compliant with established definitions, standards, business rules, and procedures.
Conduct routine and targeted data quality reviews; identify discrepancies or gaps, investigate possible 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 for questions about 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 definitions, standards, quality expectations, stewardship responsibilities, and governance processes.
Represent CMC Regulatory Affairs in PDM-wide data governance forums and working groups, providing regulatory subject matter input and communicating decisions and requirements to the function.
Monitor data quality, identify recurring issues and trends, and recommend improvements to upstream processes to prevent future 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 application of 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 for regulatory data and content.
Participate in requirements development, process review, 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 reflect regulatory data definitions, standards, quality expectations, and user needs.
Support regulatory content management, including metadata, taxonomy, traceability, structured content, content reuse, and lifecycle management.
Partner with Portfolio Insights & Analytics to improve the 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.
Model inclusion and incorporate the value of diverse teams into how teams are supported and led.
Understand employees’ skills, experiences, aspirations, and potential, and provide feedback, coaching, and insight to support their development.
Connect teams to organizational goals and purpose, remove barriers, and strengthen connections across the organization.