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...
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.
- 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.
- 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.