SRG are currently looking for a Regulatory Submissions Publisher for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Sandwich.
The Role: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.Key Responsibilities:* Responsible for the building, publishing and associated tasks for assigned Regulatory submissions within agreed timelines.* Administrative activities such as tidying and reducing backlogs on the submission fileshares and maintenance of publishing systems.* 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.* Adhere to compliance standards. Skills/Experience Required:* 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.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: email@example.com or +441615077288
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