Principal Scientist, Regulatory CMC

Role: Principal Scientist, Regulatory CMC, responsible for developing global regulatory strategies and preparing dossiers for biologics, including cell and gene therapies, at ImmunityBio. Main objectives include managing CMC module preparation in eCTD format, supporting lifecycle submissions, and liaising with cross-functional teams on regulatory requirements. Responsibilities encompass preparing and reviewing CTD documents, contributing to submission strategies, and responding to health authority inquiries. Requirements: Bachelor’s degree with 10+ years, Master’s with 8+ years, or Doctorate with 6+ years in life sciences or related field; experience in CMC module submission and eCTD format; familiarity with biologics such as cell-based, gene therapies, or recombinant proteins; strong knowledge of health authority guidance and electronic document management. Preferred skills include experience with biologic drugs, regulatory submissions outside the US, and excellent organizational and communication skills. The position is based onsite in Summit, NJ, with standard work hours, and candidates should be prepared for a fast-paced environment with deadlines.