Associate Director, Health Authorities

Role: Associate Director, Health Authorities, responsible for advancing global clinical regulatory compliance for ImmunityBio's investigational and marketed products. Core duties include leading health authority interactions, managing preparation and submission of regulatory dossiers (INDs, CTAs, BLAs, MAAs), overseeing staff activities, and ensuring adherence to evolving regional and local guidance. The position involves managing external stakeholder engagement, coordinating responses to agency queries, and maintaining document control systems. Qualifications: Bachelor's in life sciences or related field with 10+ years of experience; or Master's with 8+ years; or Doctorate with 6+ years. Must have prior experience managing staff, preparing clinical modules in eCTD format, and organizing responses to health authority requests. Preferred skills include deep knowledge of health authority guidelines, clinical research, GxP practices, and regulatory submission processes outside the US. The role is based onsite in Summit, NJ, with a standard M-F schedule. Salary ranges from $185,000 to $203,500, with discretionary bonus and equity. High-value specifics: focus on clinical regulatory work for biotech/pharma products, with broad scope including IND/CTA/ BLA/MAA submissions, compliance, and stakeholder engagement.