Regulatory Documentation Specialist II

Position Summary

The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation and will provide support in the management and publishing of documents ensuring conformance with Health Authority requirements, assisting with document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.

• Create and maintain electronic project folders for projects
• Generate electronic files for working documents
• Format documents per stipulated style guides (reports, assessments, regulatory submissions, letters, etc.)
• Format and compile documents according to Regulatory Agency requirements
• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docu Bridge), and complete external hyperlinks to other documents/datasets on the XML backbone
• Ensure working files, forms, sign-out sheets, and archives are organized and maintained per SOPs and Health Authority requirements
• Prepare document shells for inclusion of text and data
• Assist in training Regulatory Documentation Specialists; provide post‑training support and answer questions
• Perform ad‑hoc and cross‑functional duties/projects as assigned

• Bachelor’s degree in life sciences or technical discipline with 2+ years regulatory operations experience in biotechnology/pharmaceutical industry; or
• High school diploma with 6+ years regulatory operations experience in biotechnology/pharmaceutical industry

• Working knowledge of Health Authority document management/electronic submission guidance
• Working knowledge of Electronic Document Management Systems
• Working knowledge of Veeva Vault, especially Veeva RIM
• Ability to meet deadlines and adapt to changing requirements/priorities
• Strong organizational skills, written/oral communication, and attention to detail

• On‑site (Mon–Fri) in Summit, NJ