Regulatory Publishing Manager

Role Description

The Regulatory Publishing Manager supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment. This role focuses on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation. This position works within submission documents to ensure technical accuracy, formatting quality, and alignment with global regulatory standards. The role partners closely with document authors and regulatory stakeholders to embed quality into source documents, reduce time-to-file, and improve document reusability. This is an evolving environment requiring a self-starter comfortable working with refining templates, checklists, and processes.

• Format complex regulatory documents in Microsoft Word to meet submission-ready standards.
• Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices.
• Convert Word source files into compliant, high-quality PDFs.
• Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality.
• Support report-level publishing (e.g., clinical reports, protocols, periodic reports).
• Ensure alignment with global regulatory publishing standards and eCTD requirements.
• Partner with document authors and SMEs to build quality into Word source documents early.
• Provide guidance on submission-ready formatting standards.
• Support refinement of evolving submission checklists and templates.
• Manage multiple concurrent document priorities independently.

Qualifications

• 5–7 years of global regulatory publishing experience.
• Strong knowledge of eCTD structure and electronic submission requirements.
• Experience with Veeva Vault Publishing (direct experience strongly preferred).
• Advanced Microsoft Word formatting expertise.
• Experience generating submission-ready PDFs.
• Ability to work independently in a developing, non–cookie-cutter environment.
• Strong attention to detail and quality mindset.
• Effective cross-functional communication skills.

Requirements

• Bachelor’s degree preferred but not required.
• Experience supporting global regulatory submissions required.
• Experience working in a system transition or evolving publishing environment preferred.

Benefits

• Contract Length: Through the end of the year, with the chance to extend.
• Pay Range: $65/hr. - $75/hr.
• Shift/Hours: Monday - Friday. Remote. EST hours.