Regulatory Operations Specialist

Job Summary

A company is looking for a Regulatory Operations Documentation Specialist (Contractor).

Key Responsibilities

• Assist in performing document formatting per company standards for submission-related documentation
• Assist in the remediation of PDF documents by bookmarking, hyperlinking, and quality control to ensure compliant electronic files
• Provide support to the Regulatory Operations team and general assistance to the Regulatory Affairs department as needed

Required Qualifications

• High school degree required; associate's degree preferred
• Minimum of 2 years experience in regulatory affairs within a pharmaceutical or biotechnology company
• Proficient in MS Office and Acrobat Adobe
• Experience with ISI Toolbox or equivalent software packages
• Experience with database systems; Veeva is a plus