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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