Principal Regulatory Publisher

Job Summary

Leading publishing projects independently, the full-time Principal Regulatory Operations Publisher will finalize and publish regulatory documents for electronic submission while supporting various teams and mentoring junior members in a fully remote environment.

Key responsibilities

• Oversee the finalization and publishing of regulatory documents for electronic submissions
• Support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams in project execution
• Act as a mentor to junior team members and serve as a point of escalation for technical questions

Required qualifications

• Bachelor's Degree in a scientific discipline with at least 8 years of relevant experience in regulatory publishing
• Proficiency in Adobe Acrobat, ISIToolbox, and publishing software (e.g., eCTDmanager, DocuBridge)
• Demonstrated ability to lead project teams and manage major dossier submissions independently
• Experience with global submissions, including FDA and EMA, is strongly preferred
• Proficiency with medical and statistical terminology is required