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1007 Regulatory Affairs Associate

Pleasanton, CA
Regulatory Affairs Associate
Pleasanton, CA
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"
Shagun Sachdeva
Senior Technical Recruiter
Desk: 408-385-9607; Fax: 888-400-2698
email: shagun@reqroute.com
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Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.  
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)


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