The successful candidate will be responsible for the daily operational activities for regulatory submissions and archives in accordance with agency requirements and company standards.
Location: Hertfordshire (1 day a week working from home)
Salary: Competitive + benefits & bonus
The Regulatory Publisher is responsible for planning, electronically formatting and compiling regulatory submissions to achieve client deliverables and ensure quality, accuracy, and submission readiness. This includes:
- Applying full hyperlinking and bookmarking, performing quality control checking and being responsible for troubleshooting any publishing related activities and performing document level publishing tasks.
- Ensuring consistency, completeness and adherence in accordance with Regulatory agency guidance and specifications, whilst also complying with internal procedures.
- Providing guidance on good documentation and lifecycle management.
- The ability to manage and prioritize multiple tasks in a fast-paced environment whilst maintaining submission timelines.
- Staying current with new eCTD guidance and Global Health Authorities Submission Requirements.
- Preparing and formatting a variety of routine and non-routine Word and PDF documents
- Collaborating with project managers/leads to discuss preparation and submission timelines
- Bachelor’s Degree or commensurate experience
- Minimum of 1-2 years’ experience with electronic regulatory submission, associated publishing tools, templates.
- Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of DXC Toolbox (ISI Toolbox)
- Knowledge of the regulations and processes that govern content, maintenance and submission of controlled documents required by regulatory authorities
- Excellent communication skills, both verbal and written
- Exceptional attention to detail as well as organizational skills, including the ability to prioritize and multitask