311 Publisher

We are looking for a Regulatory Publisher to work in NIGHT SHIFT/ US SHIFT which would include the following responsibilities:
ResponsibilitiesManage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.Perform document management tasks and post-submission activities including file transfer, tracking, database updates, and archival.Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.EducationBachelor's degree in Life Sciences or related field.Experience3+ years of experience in eCTD publishing.Publishing in eCTD, NeeS, ePaper, and ACTD formats for EU, US, CA, AU, GCC, ASEAN, and other regions. Coordination and planning of projects that are assigned.Publish submissions in eCTD and Nees format. PDF editing in Adobe Pro, ISI toolbox/evermap (bookmarks, TOC, hyperlinks, etc.). Use of publishing tools (eCTDManager preferred). Comfortable in using eDMS Systems. Desirable: RA Knowledge.
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