Director, Regulatory Affairs - Global Labeling

The Director, Regulatory Affairs - Global Labeling will be responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Gilead products to ensure compliance with governing laws, regulations, and company policies. They will lead the development of labeling strategies for multiple products, manage labeling negotiations with regulatory authorities, and advise cross-functional partners on labeling matters. Responsibilities include leading impact assessments on major global labeling issues, preparing and submitting USPIs as part of BLAs, sBLAs, NDAs, or sNDAs, and assisting with governance and decision-making meetings related to regulatory labeling. The role also involves leading initiatives to improve Regulatory Affairs capabilities and potentially training cross-functional partners on labeling processes and policies.