My client, an expanding Clinical Research Organisation are currently seeking to recruit a Regulatory Submissions Manager to join their Clinical Operations team. This position plays...
My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Submissions Publisher on an initial 6 Month contract to be based at their offices in Kent.
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 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.
- Support global/local teams publishing teams when the need arises
- Adhere to P compliance standards.
- Experience of using various publishing tools such as ISI Publisher and proven knowledge of eCTD formats
- 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 feel you have the right skills and experience for this role please apply online or call 01753 589626.
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.