Sr Director, 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 yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Gilead is seeking a Senior Director, Regulatory Data & Content to serve as the data domain leader for CMC Regulatory Affairs and establish the strategy, governance, standards, and capabilities required to manage regulatory data and content as critical enterprise assets.

This role is accountable for the CMC Regulatory Affairs data domain, including regulatory data definitions and standards, data quality expectations, master data management, stewardship, and governance. The Senior Director will represent CMC Regulatory Affairs in PDM-level and cross-enterprise data and content initiatives, with authority to establish regulatory positions, make decisions on behalf of the function, and ensure enterprise approaches meet regulatory business and compliance needs.

The role will also shape the evolution of regulatory data and content management across its lifecycle and establish the data and content foundations necessary for advanced analytics, automation, artificial intelligence, and increasingly structured and data-driven regulatory interactions. Working closely with Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, Regulatory Affairs, IT, and other PDM functions, the Senior Director will ensure regulatory information is trusted, governed, interoperable, traceable, reusable, and positioned to support both current operations and future regulatory capabilities.

Key Responsibilities 

Regulatory Data Strategy, Governance & Domain Leadership 

• Serve as the data domain leader for CMC Regulatory Affairs, accountable for regulatory 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 for critical regulatory data. 

• Represent CMC Regulatory Affairs in PDM and enterprise data and content governance, with authority to establish regulatory positions, negotiate standards, make commitments on behalf of the function, and ensure enterprise approaches meet regulatory needs. 

• Partner with Clinical Regulatory Affairs and other functions to drive alignment of regulatory data definitions, standards, governance, and information models. 

• Assess the impact of new and evolving health authority expectations for structured data and content and translate those developments into internal data, content, governance, and capability requirements. 
   

Regulatory Content & Information Strategy 

• Define and advance CMC Regulatory Affairs content management strategy and standards across the regulatory lifecycle, enabling effective creation, management, traceability, reuse, and maintenance of regulatory information. 

• Partner with regulatory content owners and Digital Enablement to advance structured and componentized content, metadata, taxonomy, content reuse, and evolving approaches to regulatory authoring and submission. 

• Ensure data and content strategies evolve as an integrated regulatory information ecosystem supporting both human and machine consumption. 

Digital, AI & Analytics Enablement 

• Establish the trusted, governed, and interoperable data and content foundations required for digital capabilities, analytics, automation, and artificial intelligence. 

• Lead the strategy to make regulatory information AI-ready, including appropriate structure, metadata, provenance, traceability, reuse, interoperability, and controls. 

• Serve as a key business subject matter expert for regulatory information systems and platforms while maintaining clear separation between data/content domain ownership and digital platform or system ownership. 

• 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 leverage authoritative regulatory information and established standards. 

• Partner with Portfolio Insights & Analytics to ensure regulatory data are accessible, trustworthy, and fit for analytics, reporting, and organizational decision-making. 

Internal and External Leadership and Influence 

• Serve as a senior advisor to CMC Regulatory Affairs leadership on regulatory data, content, governance, information management, and emerging information capabilities. 

• Lead and develop a mixed workforce responsible for master data management, data stewardship, and regulatory data operations, ensuring critical regulatory data remain under appropriate internal ownership and accountability. 

• Establish clear 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. 

• Partner closely with Digital Enablement, Regulatory Operations & Digital Enablement, and Portfolio Insights & Analytics to create an integrated operating model connecting trusted information, effective processes, enabling technology, and actionable insights. 

• Build strong partnerships across Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, IT, and other PDM functions to ensure regulatory information requirements are incorporated into broader enterprise data and content strategies. 

• Influence senior stakeholders across functional and organizational boundaries and drive resolution of complex data and content issues where ownership, standards, or business requirements intersect. 

• Represent Gilead, as appropriate, in external industry consortia, standards organizations, and regulatory forums related to regulatory data, content, information management, and digital regulatory evolution. 

• Bring external developments and leading practices into the organization and influence internal and industry approaches where appropriate. 

Basic Qualifications
 

• Bachelor's Degree and 14 years’ experience OR
• Masters' Degree and 12 years’ experience OR
• PhD and 12 years’ experience
  

Preferred Qualifications 

• 14+ Years with BA/ BS; 12+ Years with MA/ MS/ MBA/ PharmD/ PhD; Advanced Degree(s) in a scientific field is preferred  

• Extensive experience in the pharmaceutical or biotechnology industry, 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 experience establishing data governance, data 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, with demonstrated ability to navigate differing data, content, process, and lifecycle requirements and establish integrated regulatory approaches. Experience spanning both regulatory domains strongly preferred. 

• 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. 

• Demonstrated understanding of modern data architecture, interoperability, structured content, automation, analytics, and artificial intelligence and their application within regulated business processes. 

• Experience establishing data and content foundations that enable analytics, automation, AI, or other advanced digital capabilities. 

• Demonstrated 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. 

• Strong strategic thinking with demonstrated ability to translate future regulatory and technology trends into practical 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. 

• Experience participating in or representing an organization through external industry groups, standards bodies, or regulatory information initiatives is preferred. 

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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.

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.