Regulatory Affairs Assistant

W2 Contract

Salary Range: $41,600 - $52,000 per year

Location: South San Francisco, CA - Hybrid Role

Job 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 Modules
Obtain competency in Veeva Vault Systems document management modules
Assess the acceptability of regulatory documentation to comply with FDA regulatory requirements
Review past FDA submissions to identify previous commitments
Provide support to external inspections and audits

Requirements and Qualifications:

Data entry experience
Veeva Vault experience
Some college experience or current enrollment
Strong communication skills

Desired Skills and Experience

Veeva Vault, data entry, document management, FDA

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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Regulatory Affairs Assistant