This attractive Regulatory Submissions Coordinator job is a great opportunity to join one of the pharma industry's biggest and most prestigious organisations. The company is located in London and has been working for over a 150 years across multiple therapy areas including cardiovascular, neurology and immunology. This role will be based in Kent, UK on a contract basis.
- This Regulatory Submissions Coordinator 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.
- Support global/local teams publishing teams when the need arises
- Adhere to the company's compliance standards.
Education, Skills and Experience:
- 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
- Proven technical aptitude
- Pharmaceutical Knowledge and experience
- Experience of using various publishing tools such as ISI Publisher and proven knowledge of eCTD formats
- 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
- Demonstration of experience working in a customer service environment
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Elise Lambeth on +44 207 4400 633 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.