Regulatory Publishing Consultant

Key Responsibilities (Deliverables-Focused)

• Prepare submission-ready documents and components
• Format and QC Word and PDF documents for submission readiness, including layout, styles, headers/footers, pagination, cross-references, and consistency checks.
• Apply advanced editorial/quality tools (PerfectIt, ISI Toolbox) to improve accuracy, consistency, and compliance with agreed templates/standards.
• Create and QC PDFs using Adobe Acrobat Pro, including:
• Bookmarking and hyperlinking
• Document assembly/combination and file optimization
• Navigation and functional QC (links/bookmarks/tables/TOCs)
• File naming, version control, and readiness checks
• Support submission package readiness and provide required artifacts (e.g., package inventories, QC checklists).
• Support dispatch activities through ESG as scoped (or coordinate with internal staff managing ESG), ensuring confirmation evidence is captured and retained.
• Support reference and document management
• Support reference management activities in EndNote (as needed for documents requiring citations/bibliographies).
• Cross-functional coordination
• Cross-coordinate with Regulatory Affairs, Medical Writing, and Quality contacts to obtain inputs, clarify requirements, and deliver completed outputs aligned to agreed timelines.
• Communicate risks early (e.g., missing source content, formatting issues, late changes impacting timelines).

Required Qualifications

• 3–5 years of experience in Regulatory Publishing / Regulatory Operations within biotech/pharma, CRO, or consulting environment.
• Demonstrated hands-on experience producing submission-ready outputs, including advanced formatting and PDF QC.
• Proficiency with:
• PerfectIt
• ISI Toolbox
• ESG (Electronic Submissions Gateway) (hands-on or strong familiarity, as scoped)
• Adobe Acrobat Pro
• Microsoft Word (advanced)
• EndNote
• SharePoint
• Strong attention to detail, document-quality mindset, and ability to manage multiple priorities under deadline.
• Ability to work independently in a remote environment with clear, proactive communication.

Preferred Qualifications

• Experience supporting eCTD and/or non-eCTD publishing workflows (region-specific experience a plus).
• Familiarity with common regulatory document standards and expectations (e.g., ICH structure awareness).
• Experience working with cross-functional submission teams and tight submission timelines.