Senior Associate, Regulatory Affairs

Role: Senior Associate Regulatory Affairs supporting global regulatory submissions and process improvements for oncology drug development. Responsibilities: assist in preparing, reviewing, and coordinating regulatory documents, manage regulatory intelligence newsletters, support RIM system maintenance, and collaborate with global teams and vendors. Requirements: Bachelor's degree, 2+ years in Regulatory Affairs within a drug or biologics company, familiarity with FDA and ICH guidelines, proficiency in MS Office, Adobe, and electronic document management. Preferred: experience in oncology, handling complex regulatory submissions. HighValue: oncology (cancer immunology), drug/biologics development, regulatory submission support, global CTA management, process improvement initiatives. WorkSetup: based in Redwood City, CA; salary range $120K-$150K, with consideration for market and experience.