Regulatory Operations Specialist

Job Summary

Supporting the Regulatory Operations team remotely, the contract 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 of PDF documents, ensuring regulatory compliance through proper bookmarking and hyperlinking
• Manage the archiving and retrieval of correspondence and documents related to Health Authorities

Required qualifications

• High school degree required; Associate's degree preferred
• Experience in the pharmaceutical industry is a plus
• Proficiency in Microsoft Office and Adobe Acrobat
• Familiarity with ISI Toolbox or equivalent software packages
• Experience with database systems, with Veeva as a plus