Associate Director, Regulatory & Medical Writing

Role: Associate Director, Regulatory & Medical Writing, leading the authoring, review, and approval of key regulatory documents to support clinical development and regulatory submissions. Responsibilities: develop a wide range of documents including clinical protocols, study reports, Investigator’s Brochures, IND/NDA submissions, and health authority responses; ensure content consistency, strategic messaging, and compliance with standards; manage documentation processes, timelines, and cross-functional collaboration; oversee external resources as needed; represent regulatory writing in project teams. Requirements: 6-8+ years in regulatory/medical writing within pharma/biotech, experience with clinical document development across early to late-stage development, knowledge of health authority guidelines (ICH, eCTD), strong organizational and communication skills, proficiency with document management tools and project planning software. Preferred: experience with ex-US submissions, familiarity with biologics or targeted therapeutics, and working in multidisciplinary teams. HighValue: biopharma (clinical development), documentation for INDs, NDAs, BLA, MAA, and global submissions, regulatory compliance, cross-functional collaboration. WorkSetup: onsite Brisbane, CA; travel not specified.