Regulatory Documentation Specialist III

Position Summary

The Specialist III, Regulatory Documentation will report to the Director, Regulatory Documentation and will provide expertise and guidance in the management and publishing of documents ensuring their conformance with Health Authority requirements. This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.

Essential Functions

• Create and maintain electronic project folders for projects
• Serve as an advisor to internal departments in the preparation and submission of regulatory documentation
• Generate electronic files for working documents
• Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
• Format and compile documents according to requirements specified by Regulatory Agencies
• QC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by others
• Create new submissions in submission software following all SOPs and ensuring all checklists are completed
• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone
• Submit documents to Health Authorities
• Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
• Prepare templates and document shells for inclusion of text and data
• Affiliate in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed
• Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
• High school diploma with 9+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required

Knowledge, Skills, & Abilities

• Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission
• Expert knowledge of Electronic Document Management Systems
• Strong knowledge in Veeva Vault especially Veeva RIM
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail

Working Environment / Physical Environment

• This position works on-site (Monday through Friday) in Summit, NJ.
• Regular work schedule is Monday – Friday, within standard business hours.
• Flexibility is available with manager approval.
• This position may need to sit for long periods of time and use various computer programs.
• The desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with colleagues throughout the day, often on a project-team basis.