Job Title: Regulatory - Submissions Publisher
Job Description: Role Purpose:
This role works within a team to create Regulatory Agency Submission Packages (Dossier) using 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 authorisation approval for pharmaceutical products.
- Responsible for the building, publishing 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 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
- Support global/local publishing teams when the need arises
- Administrative activities such as tidying and reducing backlogs on the submission fileshares and maintenance of publishing systems
- Adhere to compliance standards
Training and Education Preferred
- 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
Prior Skills/Experience Preferred
- Proven technical aptitude
- Quick learner with ability to multi-task
- Ability to work with accuracy and attention to detail
- Ability to work with autonomy and/or part of a team in a busy environment
- Demonstrated ability to work in a highly regulated environment
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