Associate Director, Regulatory Submission Management

Role: Associate Director of Regulatory Submission Management (RSM) at Gilead, focusing on strategic planning and execution of complex global regulatory submissions across multiple programs. Responsibilities include developing global filing plans, overseeing submission lifecycle, managing timelines and stakeholder communications, and leading process improvement initiatives. The role involves managing 2-4 major submissions such as NDAs, BLAs, or INDs, coordinating with regulatory partners, and ensuring compliance with global health authority requirements. Qualifications: 10+ years of relevant experience with BS/BA or 8+ years with MS/MA/MBA, extensive knowledge of drug and biologics development, and proven success in managing multiple regulatory submissions. Preferred skills include leadership in matrix environments, project management certifications (e.g., PMP), familiarity with regional regulatory requirements (US, EU), and experience with digital tools like Veeva or Smartsheet. High-value specifics: focus on biopharma products in infectious diseases, oncology, and inflammatory conditions; involvement in late-stage clinical or post-approval submissions; strong emphasis on collaboration with cross-functional teams including Regulatory Affairs, Medical, and CMC. Work setup is based in Foster City, CA, with some travel as needed. The role emphasizes leadership, strategic thinking, and technical expertise in global regulatory processes within a fast-paced biopharma environment.