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: oversee planning and execution of high-level regulatory submissions such as NDAs, BLAs, MAAs, and INDs; develop global filing plans; coordinate with RA Liaisons and GRAD to ensure timely, compliant submissions; lead multiple submission projects simultaneously; drive process improvements and contribute to infrastructure development; lead stakeholder communications and manage submission lifecycle from planning to delivery. Qualifications: 10+ years' experience with BS/BA or 8+ years with MS/MA/MBA in regulatory affairs, project management, or related biopharma fields; extensive knowledge of drug and biologics development, global regulatory requirements (US, EU), and submission tools (e.g., Veeva, Smartsheet). Preferred: experience managing multiple complex submissions, leadership in matrixed settings, certifications like PMP; strong negotiation, communication, and strategic skills; familiarity with Agile methodologies. High-Value specifics: focus on biologics and small molecules for infectious diseases and cancers, with global regulatory scope, including US and EU markets. Work setup: based in Foster City CA, no relocation; travel as needed.