Regulatory Document Specialist

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. sCreate and maintain electronic project folders for project sMaintain Veeva RIM by uploading all submission, Health Authority correspondence, etc .Serve as an advisor to internal departments in the preparation and submission of regulatory documentatio nGenerate electronic files for working document sFormat 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 Agencie sQC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by other sCreate new submissions in submission software following all SOPs and ensuring all checklists are complete dPublish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbon eSubmit 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 requirement sPrepare templates and document shells for inclusion of text and dat aAssist 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 complete dCollaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer neede dPerforms ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities Education & Experien ceBachelor’s Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; orHigh school diploma with 9+ years of regulatory operations experience in the biotechnology or pharmaceutical industry requir d Knowledge, Skills, & Abiliti esExpert knowledge of Health Authority procedures and guidance regarding document management and electronic submissi onExpert knowledge of Electronic Document Management Syste msStrong knowledge in Veeva Vault especially Veeva R IMAbility to work with firm deadlines and adapt quickly to changing requirements and prioriti #J-18808-Ljbffr Avetix Bio