Director, Regulatory Affairs Labeling Compliance

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.

FUNCTION: Regulatory Affairs (RA) Labeling

POSITION OVERVIEW: Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies. You will play a key role in advancing compliance excellence within the Global Labeling team at Gilead. This position will focus on optimizing tools, systems, and processes to support proactive compliance management. Collaborating closely with Global Labeling, Regulatory, Patient Safety and Manufacturing teams, you will ensure the seamless execution of labeling changes and provide critical support during global audits and inspections. As an individual contributor, you will work cross-functionally across Gilead and with strategic partners to enhance the efficiency, accuracy, and compliance of Company Core Data Sheets (CCDS) alignment, distribution, as well as the tracking of labeling changes. This newly created role within the Innovation, Content, and Execution (ICX) team carries significant responsibility for shaping and evolving global regulatory and labeling policies, tools, procedures, and capabilities—driving continuous improvement and innovation across Gilead.

EXAMPLE RESPONSIBILITIES:

• Operational Excellence: Oversee the development and management of implementation of global labeling and review processes, metrics, and systems. Provide oversight of country labeling deviations from the CCDS through reporting and collaboration with Global Labeling Leads. Support the design, implementation, and continuous improvement of standardized processes, Standard Operating Procedures (SOPs), and work instructions related to labeling compliance and tracking. Work to optimize the workflow for the distribution and tracking of CCDS, ensuring seamless communication and execution across all departments. Provide guidance to liaison and affiliate teams on the implementation of labeling changes, ensuring consistency and quality at every stage of the product lifecycle. Develop key performance indicators (KPIs) and identify opportunities for further operational improvements, driving a culture of continuous improvement within labeling.
• Innovation in Tools and Technologies: Support key initiatives aimed at identifying, evaluating, and implementing new tools, technologies, and systems for the distribution of global labeling changes. Support the integration of advanced tools for efficient management of CCDS distribution, regulatory tracking, and labeling change implementations across multiple affiliates. Inform Gilead on emerging technologies within regulatory labeling to ensure the use of state-of-the-art tools, which will reduce lead time and improve the accuracy of labeling updates globally.
• Proactive Compliance Management: Support the development and compliance to labeling processes in place to meet global regulatory requirements and internal compliance standards. Proactively track and report on safety-related changes to labeling, ensuring that the most current and accurate information is consistently reflected in CCDS documents. Monitor and maintain audit-ready documentation for labeling activities, ensuring that all changes are traceable and fully compliant with local and international regulations. Collaborate with stakeholders to ensure compliance with regulatory bodies and inspections, providing necessary data when required. Support the LAT and Pharmacovigilance team during regulatory inspections and audits, ensuring the accuracy and availability of relevant labeling documentation.
• Impactful Execution: Collaborate with Labeling, Liaisons, Affiliates and PDM to ensure all packaging and labeling changes are executed within required timelines. Manage the tracking and coordination of labeling activities, including artwork approvals, change management, and regulatory assessments. Ensure that all internal stakeholders, including regulatory affairs, legal, and marketing teams, are aligned and aware of any updates to labeling and packaging requirements. Prioritise tasks effectively, ensuring that labeling changes are implemented on schedule to meet regulatory deadlines and support successful product launches.

REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience: Extensive experience in prescription drug labeling. Extensive experience leading development of end to end labeling process regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products. Significant experience in global management of drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets. Experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.