Regulatory Publishing Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop documents and components that are ready for submission.

• Format and perform quality checks on Word and PDF documents to ensure they are ready for submission, focusing on layout, styles, headers and footers, pagination, cross-references, and consistency.

• Utilize advanced editorial and quality tools (PerfectIt, ISI Toolbox) to enhance accuracy, consistency, and adherence to established templates and standards.

• Generate and validate PDFs using Adobe Acrobat Pro, including: Bookmarking and hyperlinking, document assembly and optimization, navigation and functional quality checks (links, bookmarks, tables, and TOCs), file naming, version control, and readiness assessments.

• Assist in preparing submission packages and provide necessary artifacts (e.g., package inventories, QC checklists).

• Facilitate dispatch activities through ESG as outlined (or coordinate with internal personnel managing ESG), ensuring that confirmation evidence is documented and preserved.

• Aid in managing references in EndNote as needed for documents that require citations and bibliographies.

• Organize working files and deliverables within SharePoint, adhering to folder structures, naming conventions, and document control standards.

• Collaborate effectively with Regulatory Affairs, Medical Writing, and Quality teams to gather inputs, clarify requirements, and deliver completed outputs in accordance with established timelines.

• Proactively communicate potential risks (e.g., missing source content, formatting challenges, late changes affecting timelines).

⛳️ Requirements

• 3–5 years of experience in Regulatory Publishing or Regulatory Operations within the biotech, pharmaceutical, CRO, or consulting sectors.

• Proven experience in producing submission-ready outputs, with an emphasis on advanced formatting and PDF quality control.

• Proficient in: PerfectIt, ISI Toolbox, ESG (Electronic Submissions Gateway) (hands-on experience or strong familiarity, as applicable), Adobe Acrobat Pro, Microsoft Word (advanced), EndNote, and SharePoint.

• Exceptional attention to detail, a document-quality mindset, and the capability to manage multiple priorities under tight deadlines.

• Ability to work independently in a remote setting while maintaining clear and proactive communication.

🏝️ Benefits

• ProKidney is committed to equal employment opportunity and does not discriminate against any applicant based on race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

• Applicants must be eligible to work in the United States without the need for a work visa or residency sponsorship.