Mahima Shah

➢ Responsible for formatting, compiling, and electronic filing of regulatory submissions and Documents.
➢ Working closely with content providers to produce high quality submission-ready documents that adhere to internal and external electronic submission guidelines
➢ Providing Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/linking, and document verification) and compiles Module 1-5 in eCTD format, Paper or NeeS (where applicable).
➢ Ensuring submission documents meet the level of technical integrity required for publishing tools
➢ Management all technical aspects for assigned submissions and status updates to concerned parties.
➢ Collaborate with Regulatory Affairs Manager for planning, preparation, publishing, and quality control of submissions
➢ Formatting of regulatory documents and manage document templates to assure the standards outlined by the authoring style guide are met.
➢ Providing assistance to authors of multiple functional areas to ensure documents are compliant with authoring style guide.
➢ Assist with activities associated with preparedness for future eCTD filings. This may include business process documentation,system testing, validation, assisting with pilot submissions, etc.
➢ Performing quality review of published output for completeness & correctness in formatting and navigation. Verify that final customer and/or agency deliverables meet all applicable regulatory standards.
➢ Expert knowledge of internal and external publishing standards
➢ Performing electronic publishing tasks including assembling submissions electronically using eCTD software and providing final output on paper and/or electronic media
➢ Maintaining familiarity and adherence to the standard operating procedures and work instructions. Writes validation plans and help manage publishing center software implementations.
➢ Other duties, as assigned, or as business needs require.