Regulatory Affairs Assistant
Bayside Solutions - Hayward, CA
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Regulatory Affairs AssistantW2 ContractSalary Range: $41,600 - $52,000 per yearLocation: South San Francisco, CA - Hybrid RoleJob Summary:As a part of our Regulatory Affairs FDA Inspection Preparedness and Readiness initiatives, you will organize and identify gaps in Regulatory files and documents according to 21 CFR Part 11, 21 CFR 600.12, and FDA Compliance Program 7348.810. You will use Veeva Vault document management system as the electronic filing system to organize and store documents for external audits and inspections.Duties and Responsibilities:Facilitate, oversee, and manage the transfer of Regulatory Affairs documents to Veeva Vault Document Management ModulesObtain competency in Veeva Vault Systems document management modulesAssess the acceptability of regulatory documentation to comply with FDA regulatory requirementsReview past FDA submissions to identify previous commitmentsProvide support to external inspections and auditsRequirements and Qualifications:Data entry experienceVeeva Vault experienceSome college experience or current enrollmentStrong communication skillsDesired Skills and ExperienceVeeva Vault, data entry, document management, FDABayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at .
Created: 2024-10-11