Regulatory Publishing Consultant

Responsibilities

• Prepare submission-ready documents and components by formatting and performing QC on Word and PDF files
• Apply advanced editorial tools like PerfectIt and ISI Toolbox to ensure compliance with standards
• Perform PDF assembly including bookmarking, hyperlinking, and file optimization using Adobe Acrobat Pro
• Support submission package readiness and dispatch activities through ESG
• Manage references in EndNote and maintain working files within SharePoint
• Coordinate with Regulatory Affairs, Medical Writing, and Quality teams to meet timelines

Requirements

• 3–5 years of experience in Regulatory Publishing or Regulatory Operations within biotech, pharma, or CRO environments
• Proficiency with PerfectIt, ISI Toolbox, ESG, Adobe Acrobat Pro, advanced Microsoft Word, EndNote, and SharePoint
• Demonstrated experience in producing submission-ready outputs and advanced PDF QC
• Strong attention to detail and ability to manage multiple priorities under deadlines
• Ability to work independently in a remote environment
• Must be eligible to work in the United States without sponsorship

Preferred Qualifications

• Experience supporting eCTD and/or non-eCTD publishing workflows
• Familiarity with ICH structure and common regulatory document standards
• Experience working with cross-functional submission teams under tight timelines

About the Company

ProKidney is a biotechnology company focused on developing cell therapies for kidney disease.