Regulatory Submission Publisher

Job Ref: J28369
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 07 September 2018
  • Kent, England, UK
  • Competitive
    ANNUM
  • Natasha Rollason

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The Role:

This role works within a team to create Regulatory Agency Submission Packages (Dossier) using a number of build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Hub Submission Managers and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorization approval for pharmaceutical products.

Responsibilities:

  • Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
  • Adhering to quality control procedures and standards related to submission publishing.
  • Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
  • Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
  • Responsible for key projects within a specific region to implement and train on any external agency updates for procedures or requirements.
  • Responsible for leading major submissions. Coordinating the allocation of all publishing activities around the global publishing hubs to meet agreed deadlines, whilst tracking and monitoring all issues.
  • Liaising with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.
  • Monitoring local mailbox for any urgent publishing requests and assigning to resources available within India or Sandwich
  • Support global/local teams publishing teams when the need arises
  • Adhere to company compliance standards.

Education:

  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Functional and technical knowledge and skills to do the job at a high level of accomplishment
  • Experience of using various publishing tools such as ISI Publisher and proven knowledge of eCTD formats

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
07/10/2018 13:46:03
GBP .