Regulatory Operations Specialist

Job Summary

Supporting the Regulatory Operations team remotely on a contract basis, the Regulatory Operations Documentation Specialist will assist in the preparation, formatting, and quality control of submission-related documentation for electronic submissions to Health Authorities.

Key responsibilities

• Support document formatting and quality control in alignment with submission standards
• Assist in the remediation and quality control of PDF documents, ensuring regulatory compliance
• Manage the archiving and retrieval of correspondence and documents from offsite storage facilities

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
• Familiarity with database systems; experience with Veeva is a plus
• Pharmaceutical industry experience is a plus, but not required