Regulatory Documentation Specialist III

Role: Regulatory Documentation Specialist III supporting immunotherapy biotech; responsible for managing and publishing regulatory documents ensuring compliance with Health Authority standards. Core duties include creating, formatting, QC, and submitting electronic Common Technical Document (eCTD) modules using systems like Veeva Vault, and advising internal teams on document preparation. Qualifications: Bachelor's in life sciences or technical field with 5+ years of regulatory operations experience in biotech/pharma, or high school diploma with 9+ years industry experience. Skills: expertise in Health Authority procedures, electronic submission systems, and document management; strong organizational and communication skills. High-Value: focus on immunotherapy development, including FDA-approved therapies (e.g., ANKTIVA), with an emphasis on electronic submission and document control in a GMP-regulated environment. Location: on-site in Summit, NJ, with regular weekday schedule.