Manager, Regulatory Data and Content, Regulatory Affairs CMC

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead, our pursuit of a healthier world for all people has led to a cure for hepatitis C, revolutionary advances in HIV treatment and prevention, and progress across viral and inflammatory diseases and certain cancers. We set bold ambitions in our fight against some of the world’s most devastating diseases. We are united by a shared commitment to solving complex public health challenges and improving the lives of patients for generations to come. Gilead is seeking a Manager, Regulatory Data & Content, CMC Regulatory Affairs to support the quality, integrity, and effective management of regulatory data and content across the CMC regulatory lifecycle. This role serves as an operational data steward for CMC Regulatory Affairs, with responsibility for maintaining critical regulatory data, supporting data quality and governance, and ensuring information is complete, accurate, consistent, and fit for its intended use. A significant component of the role, particularly during the first year, will include direct data entry and maintenance activities, providing the individual with a strong foundation in CMC regulatory processes, data, systems, and information flows. Beyond operational stewardship, the Manager will contribute to the continued 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 will participate in emerging PDM-wide data governance structures and partner with CMC Regulatory Affairs, Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, IT, and other PDM functions to improve how regulatory information is created, governed, maintained, and used. This position provides an opportunity to develop broad expertise at the intersection of Regulatory Affairs, data, content, process, and digital capabilities while contributing to the evolution toward increasingly structured, connected, and data-driven regulatory operations. Key Responsibilities Regulatory Data Stewardship & Operations Serve as an operational data steward for CMC Regulatory Affairs, performing and supporting the creation, entry, maintenance, review, and lifecycle management of critical regulatory data in relevant regulatory and enterprise systems. Ensure regulatory data are entered and maintained accurately, completely, consistently, and in accordance with established data definitions, standards, business rules, and procedures. Perform routine and targeted data quality reviews, identify discrepancies or gaps, investigate potential root causes, and coordinate resolution with appropriate data owners, process owners, and system stakeholders. Develop a strong understanding of CMC Regulatory Affairs data, content, processes, and systems and serve as a knowledgeable resource for questions related to data entry, interpretation, quality, and use. Support ongoing data remediation, reconciliation, migration, and master data management activities as required. Data Quality & Governance Support implementation of the CMC Regulatory Affairs data governance framework, including data definitions, standards, quality expectations, stewardship responsibilities, and governance processes. Participate as a CMC Regulatory Affairs representative in PDM-wide data governance forums and working groups, providing regulatory subject matter input and bringing decisions and requirements back into CMC Regulatory Affairs. Monitor data quality and identify recurring issues, trends, or opportunities to improve upstream processes and prevent future 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 other stakeholders to promote consistent application of data standards and appropriate management of critical regulatory data. Process, Digital & Content Enablement Serve as a data and content subject matter contributor to CMC Regulatory Affairs and PDM-wide process, system, digital, and data initiatives. Review new or revised business processes to identify data and content requirements, potential quality risks, and implications for data creation, maintenance, governance, and downstream use. Support development and documentation of new processes, procedures, workflows, business rules, and operational controls related to 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 colleagues to ensure solutions appropriately incorporate regulatory data definitions, standards, quality expectations, and user needs. Support the evolution of regulatory content management, including metadata, taxonomy, traceability, structured content, content reuse, and lifecycle management. Data Use, Insights & Continuous Improvement Partner with Portfolio Insights & Analytics colleagues 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 provide visibility into 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 initiatives that make regulatory information increasingly structured, governed, traceable, reusable, and AI-ready. Basic Qualifications 6+ Years with BS/BA OR 4+ Years with MS/MA Preferred Qualifications 6+ Years with BA/ BS; 4+ Years with MA/ MS/ MBA; Degree(s) in a Life Sciences, Information/Data Management, Engineering, Computer Science preferred Relevant experience in the pharmaceutical/biotechnology industry, Regulatory Affairs, data or information management, operations, quality, or another regulated environment. Previous CMC Regulatory Affairs experience is desirable but not required. Demonstrated interest in working with data and information, with strong attention to detail and commitment to data accuracy and quality. Ability and willingness to perform detailed operational data stewardship and data maintenance activities while developing broader expertise in data governance, regulatory processes, and digital capabilities. Strong analytical and problem-solving skills, including the abili