Regulatory Operations Specialist

Job Summary

Supporting the Regulatory Operations team, the contract Regulatory Operations Documentation Specialist will assist in the preparation, formatting, and quality control of submission-related documentation for electronic submissions while working remotely.

Key responsibilities

• Support document formatting and quality control in alignment with submission standards
• Assist in the remediation and quality control of PDF documents to ensure regulatory compliance
• Archive and manage correspondence with health authorities and documents from offsite storage

Required qualifications

• High school degree required; Associate's degree preferred
• Proficient in Microsoft Office and Adobe Acrobat
• Experience with ISI Toolbox or equivalent software packages
• Experience with database systems; Veeva is a plus
• Pharmaceutical industry experience is a plus, but not required