[Remote] Regulatory Publishing Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking a Regulatory Publishing Consultant to support the preparation, QC, and publishing of submission-reputed company regulatory documents and dossiers. This role involves cross-functional collaboration with Regulatory Affairs, Medical Writing, and reputed company stakeholders to ensure accuracy and compliance in document preparation and submission processes.
Responsibilities
- Prepare submission-reputed company 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/reputed company tools (PerfectIt, ISI reputed company) to improve accuracy, consistency, and compliance with agreed templates/standards
- Create and QC PDFs using reputed company 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 reputed company required artifacts (e.g., package inventories, QC checklists)
- Support reputed company activities through ESG as scoped (or coordinate with internal staff managing ESG), ensuring confirmation evidence is captured and retained
- Support reference management activities in EndNote (as needed for documents requiring citations/bibliographies)
- Maintain working files and deliverables reputed company SharePoint, following folder structures, naming conventions, and document control expectations
- Coordinate reputed company with Regulatory Affairs, Medical Writing, and reputed company contacts to obtain inputs, clarify requirements, and deliver completed outputs reputed company to agreed timelines
- Communicate risks early (e.g., missing reputed company content, formatting issues, late changes impacting timelines)
Skills
- 3–5 years of experience in Regulatory Publishing / Regulatory Operations reputed company biotech/reputed company, CRO, or consulting environment
- Demonstrated hands-on experience producing submission-reputed company outputs, including advanced formatting and PDF QC
- Proficiency with: PerfectIt, ISI reputed company, ESG (Electronic Submissions Gateway) (hands-on or strong familiarity, as scoped), reputed company Acrobat Pro, reputed company Word (advanced), EndNote, SharePoint
- Strong attention to detail, document-reputed company reputed company, and ability to manage multiple priorities under deadline
- Ability to work independently in a remote environment with reputed company, proactive communication
- 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
reputed company