Regulatory Documentation Specialist II

Role: Regulatory Documentation Specialist supporting electronic document management and publishing for biopharma regulatory submissions. Responsibilities: create and maintain project folders, format and compile documents per regulatory standards, publish files in eCTD modules, and ensure compliance with health authority guidelines; assist and train other staff on SOPs and document control processes. Requirements: Bachelor's in life sciences or technical field with 2+ years of biotech/pharma regulatory ops experience, or 6+ years with high school diploma; strong knowledge of health authority procedures, electronic document management systems, and Veeva Vault (Veeva RIM preferred); excellent organizational, communication, and attention to detail skills. HighValue: experience in biotech/pharma regulatory document management, familiarity with eCTD publishing, working knowledge of GxP, and ability to work in a fast-paced, onsite environment. Collaboration: reports to Director, Regulatory Documentation, with cross-functional interactions. WorkSetup: on-site in Summit, NJ, with standard Monday-Friday hours; no travel specified.