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Regulatory Operations and Publishing Sr. Associate,
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Job Responsibilities:

  • Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications
  • Format MS Word and Adobe Acrobat files to a state of submission-readiness
  • Act as department liaison to publishing and archival vendors
  • Provide support to Regulatory Affairs in the creation of submissions documents
  • Manage and maintain correspondence and other records in regulatory tracking system
  • Coordinate the exchange of records using document-sharing platforms
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement process improvements

Primary Job Requirements:

  • Bachelor's degree or equivalent experience
  • 3 to 5 years of relevant Regulatory Operations experience in biotech/pharmaceutical industry
  • Strong understanding of submission requirements
  • Records management concepts, and electronic tools and systems.
  • Expert-level document formatting and submission building (eCTD and non-eCTD)
  • Expert-level knowledge of PDF Publishing tool (ToolBox preferred)
  • Proficiency in Microsoft Word, Microsoft Excel,
  • Acrobat Professional, and Sharepoint
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Excellent organization, written/verbal communication, and attention to detail

Preferred Experience:

  • Grouped and OPDP Submission experience
  • ToolBox
  • Acuta PDF
  • Extedo eCTDManager
  • Veeva Vault
  • Veeva RIMS

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