Regulatory Affairs Publisher

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 (1 day a week working from home)

Salary: Competitive + benefits & bonus

ESSENTIAL FUNCTIONS

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

KNOWLEDGE AND ABILITIES

-         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 natalie@linkfieldgroup.com or call 02071835059