Regulatory Operations - Publisher
The role is to manage the document level, submission level publishing, quality control and electronic submission of regulatory documents, including innovator molecules, branded therapeutics, generics and API.
Responsible for working with Regulatory Managers to prepare electronic dossiers for the purpose of electronic or paper submissions, using the corporate software standard.
Competent in the functionality of Electronic Document Management System (EDMS) tools, electronic publishing tools and understands requirements for eCTD submissions.
Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with agency requirements and company standards. Acts as direct liaison with Global Regulatory Affairs staff and contributing departments to facilitate effective management of submissions.
Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance.
Participates on project teams as appropriate for assigned projects and/or submissions. Maintains submission-planning schedule.
Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
Tue, 9 May 2017 13:11:07 PDT