Job Summary

A a late-stage biopharmaceutical company is in need of a Remote Regulatory Operations Publishing Manager.

Must be able to:

• Assist the Regulatory Operations Lead in the preparation of regulatory submission documents
• Format complex Word documents to generate compliant regulatory reports
• Ensure consistency across regulatory submission documents following the regulatory style guide

Position Requirements Include:

• Bachelor’s degree and 5-6 years of experience in Regulatory Operations
• Specialized skills in electronic submissions
• In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions
• Relevant experience with electronic document management and publishing systems
• Proficiency with MS Word and Adobe
• Relevant experience with eCTD Validation and viewing tools, and other publishing and QC tools