Senior Coordinator Regulatory Operations
CurrentBuild and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients.Use, manage and maintain submission files on the company shared drive and submissions drive as per company standard.Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point.Create eCTD submissions using the eCTD submissions builder, validation software and electronic submissions viewer.Create NeeS, and paper submissions as needed.Quality checking all submission types with little assistance from manager.Trouble shoot and fix issues, on a document and submission level.Send eCTD submissions via the ESG and CESG gateway.Burn CDs/DVDs, create appropriate labelling.Create courier waybills, pack and ship submission materials as needed.Enter time into Paymo, or company chosen database, on a daily basis.Attend and contribute to weekly department meetings.Maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.The Senior Coordinator will be responsible, when requested by their manager, to train other junior department members. The Senior Coordinator may be asked to complete additional and other department services as required.
