Regulatory Publishing Consultant
The Publishing Consultant will be responsible for planning, electronically formatting and compiling Global regulatory submissions to achieve client deliverables and ensure quality, accuracy, and submission readiness.
The opportunity
Support regulatory projects on behalf of clients, including supervised liaison and negotiation with regulatory authorities. Will provide excellent project support and develop clear, effective and creative publishing strategies.
Key responsibilities
- Assess priorities and set strategies to align with business needs
- Perform publishing activities including hyperlinking, bookmarking, quality control checks, troubleshooting, and document-level publishing tasks
- Ensure consistency, completeness, and adherence to regulatory agency guidance and internal SOPs
- Provide guidance on good documentation and lifecycle management practices
- Manage and prioritise multiple tasks in a fast-paced environment while maintaining submission timelines
- Stay current with eCTD guidance and global health authority submission requirements
- Prepare and format routine and complex Word and PDF documents
- Collaborate with project managers/leads to plan submission timelines
- Analyse regulatory changes for impact on projects and business strategy.
Technical Skills
- Strong experience in regulatory publishing and submission management
- Skilled in using publishing tools, document formatting, and compliance with eCTD standards.
- Proficiency in MS Office (Word, Excel, Outlook, Adobe Acrobat)
- Experience leading publishing activities for major projects and developing publishing strategies
- Ability to advise clients on applicable regulations and prepare compliant submissions
- Familiarity with regulatory lifecycle management and SOP development
- Understanding of scope management, billing, and budget control for projects
- Experience in networking and supporting business development initiatives.
About you
- Shares knowledge to close skills gaps and provides constructive feedback
- Adept at explaining complex scientific issues clearly, facilitating discussions, and building rapport
- Makes sound decisions independently, consults stakeholders early, and manages risks effectively
- Identifies opportunities for additional services, supports BD processes, and builds trusted client relationships
- Monitors workload, anticipates external factors, and adapts priorities to meet timelines
- Leads publishing activities, ensures compliance with regulatory requirements, and mentors others in publishing best practice
- Demonstrates and operates in line with the behaviours outlined in the Behavioural Competency Framework at the required level
- Degree in Life Sciences, Pharmacy, or equivalent
- Eligible to work in the UK; fluent in English.
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