Senior Associate, Regulatory Affairs

Role: Senior Associate Regulatory Affairs supporting global regulatory submissions and interactions at a biopharma focused on oncology therapeutics, specifically RAS-targeted inhibitors. Responsibilities: coordinate and compile regulatory documentation aligned with ICH, FDA, and regional guidelines; prepare routine submissions; develop and implement SOPs for tracking product events; assess regulatory backgrounds to inform development strategies; stay updated on regulatory changes; collaborate with multidisciplinary teams and represent Regulatory Affairs in project activities. Requirements: Bachelor's degree; 4+ years of regulatory experience in drug/biologics companies; familiarity with FDA regulations, ICH guidelines, and regulatory submission processes; proficiency in MS Office, document management systems; eager to develop further regulatory expertise. Preferred: oncology drug development experience; experience with large, complex submissions like NDAs; strong communication skills. HighValue: Oncology focus, biologics/drugs, development stage not specified, emphasis on regulatory compliance, global submissions, and cross-functional collaboration. WorkSetup: primarily based in Redwood City, CA, salary range $120K-$150K, with considerations for local market; full-time, onsite.