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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