Director, Regulatory Affairs Advertising and Promotion

Role: Lead regulatory strategy and oversight for Gilead's commercial advertising and promotion activities across multiple high-volume or complex pharmaceutical brands, ensuring compliance with FDA regulations and internal policies. Responsibilities: review and approve promotional materials, chair Promotional Review Committees, provide strategic regulatory guidance on marketing campaigns and product labeling, and serve as liaison to regulatory agencies like FDA/CDER/CBER. Lead or support process improvements and special projects related to regulatory governance. Advises cross-functional teams on regulatory implications of marketing initiatives. Qualifications: PharmD/PhD with 6+ years, or MA/MS/MBA with 10+ years, or BA/BS with 12+ years of relevant regulatory experience, including promotional review for prescription drugs/biologics. Preferred skills include extensive regulatory knowledge, leadership experience in regulatory strategy development, negotiation skills, and experience working with FDA. High-value: U.S. regulatory requirements for prescription drugs/biologics, experience chairing promotional review committees, managing complex regulatory interactions, and supporting multiple products. Leadership: may oversee direct reports and coach team members. Work setup: not specified, but travel may be required.