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Regulatory Affairs Publisher

Salary

£35,000 - £45,000

Location

North London, England

Job Type

Full Time

Reference No: RI2020001002

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Job Description

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
Applicant Requirements
  • 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
Reference No: RI2020001002

Hiring Manager(s)

Natalie

Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: natalie@linkfieldgroup.com

Email Natalie

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