Associate, Regulatory Operations

* Build 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 within company systems as per company standard.* Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, and Power Point.* Create eCTD submissions using an eCTD submissions builder, validation software, and an electronic submissions viewer.* Create NeeS submissions, as needed, and coordinate any necessary shipments.* Quality check and provide accurate feedback on all submission types.* Independently troubleshoot and fix issues on a document and submission level.* Send eCTD submissions via the ESG NextGen Portal.* Save submissions to external media and arrange for parcel delivery (if required).* Enter time i...