Regulatory Submissions Publisher

Lloyd Recruitment Services are delighted to be recruiting for long-standing pharmaceutical clients who are seeking a Regulatory Submissions Publisher.

Please note: this role is being offered on a temporary 12-month basis (paid week by week).

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.

Major Duties

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  Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.


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  Adhering to quality control procedures and standards related to submission publishing.


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  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.


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  Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.


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  Responsible for key projects within a specific region to implement and train on any external agency updates for procedures or requirements


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  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.


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  Liaising with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.


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  Monitoring local mailbox for any urgent publishing requests


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  Support global/local publishing teams when the need arises


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  Adhere to compliance standards

Training and Education Preferred

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  Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards


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  Functional and technical knowledge and skills to do the job at a high level of accomplishment

Prior Skills/Experience Preferred

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  Proven technical aptitude


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  Experience of using publishing tools such as Liquent InSight and proven knowledge of eCTD formats would be preferred


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  Quick learner with ability to multi-task


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  Ability to work with accuracy and attention to detail


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  Ability to work with autonomy and/or part of a team in a busy environment


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  Demonstrated ability to work in a highly regulated environment


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  Demonstration of experience working in a customer service environment

All offers are subject to security screening checks, which includes Employment, CCJ, DBS checks

NB: Lloyd Recruitment Services would like to thank you for taking the time to apply to this vacancy. However, unfortunately due to a high number of applications, we are only able to respond to shortlisted applicants. If you have not heard from us within seven days, please assume that you have not been shortlisted on this occasion. However please do join our Facebook community, to be the first to see our new positions.



Key Words: Regulatory, Submissions, Publisher, Submission Packages, Quality Control, Document Management Systems,