Manager, Regulatory Data and Content - Regulatory Affairs CMC

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 ability to identify patterns, investigate discrepancies, understand root causes, and recommend practical improvements. 

• Ability to understand and follow defined data standards, business rules, procedures, and governance requirements while identifying opportunities where those standards or processes may need improvement. 

• Experience with or demonstrated aptitude for enterprise information systems, databases, document/content management platforms, workflow technologies, or similar digital tools. Experience with Veeva Vault or regulatory information management systems is required. 

• Familiarity with data governance, master data management, data quality, metadata, controlled vocabularies, or information lifecycle management is desirable. 

• Experience participating in process design, requirements gathering, system testing, user acceptance testing, or implementation activities is desirable. 

• Knowledge of pharmaceutical development and regulatory processes is desirable; interest and ability to develop expertise in CMC Regulatory Affairs is required. 

• Strong collaboration and communication skills with the ability to work effectively with subject matter experts, process owners, system teams, and stakeholders across functions. 

• Strong organizational skills and ability to manage detailed operational responsibilities alongside project-based assignments and continuous improvement activities. 

• Curiosity about how data, content, processes, and technology connect, with an interest in developing expertise in regulatory data governance, digital capabilities, analytics, automation, and emerging technologies. 

People Leader Accountabilities

• Create Inclusion: Understand the business value of diverse teams, model inclusion, and embed the value of diversity in how teams are supported and led.
• Develop Talent: Understand employees’ skills, experiences, aspirations, and potential, and provide the feedback, coaching, and insight needed to support their continued development.
• Empower Teams: Connect teams to broader organizational goals and purpose, provide the support needed to remove barriers, and strengthen connections across the organization.

The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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