Regulatory Affairs Publisher

2019-11-27 12:00:132020-01-10LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 35,000 ~ 38,000 Competitive
Job Ref0064I0000103Ls7QAE
Job Views526

Regulatory Publisher

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 (home working also available)

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.

For further information please get in touch with Natalie Jones via or call 02071835059

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To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:


Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
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