Job Description :
Regulatory Affairs Associate
Pleasanton, CA
Contract

Technical Skills - Graduate with experience in Document Management
Technical Skills Desired - Regulatory Affairs Submission, Veeva Vault
Provide support for Regulatory Affairs managing workflow and approval process in client''s Regulatory Information Management System and formatting and Quality checks of documents that go into the system.
Facilitate the document change request (DCC) process, by providing guidance of the approved document control process, GxP and Non GxP documents in client’s designated application/Repositories/Content Management Platform
Provide word processing and formatting support for all Controlled Documents for all functions (e.g. Clinical Development, Clinical Operations, Commercial, Data Management, Legal, Finance, Facilities, HR, IT, Technical Operations, Quality, and Regulatory)
Perform Review/Quality Checks on documents regarding use of appropriate templates, appropriateness of the content as per defined Checklists, correct formatting of the document as appropriate and be the GateKeeper of the Quality of documents being approved in the system
Manage workflow and distribute and track documents through approval, make approved documents effective
Manage document database to ensure updates are individually assigned and tracked
Manage the electronic document Life Cycle process
Run reports on the status of documents (Periodic Review, document cycle time)
Support the Learning Management System to assign users and training to keep training current and accurate
Run training completion reports as required
May perform internal audits on document control or other areas of the quality system"