We are looking for an Regulatory Publisher to work in NIGHT SHIFT/ US SHIFT which would include the following responsibilities:

Responsibilities

  • Manage 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.

Education

  • Bachelor’s degree in Life Sciences or related field

Experience

  • 3+ 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.

289 Publisher

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