Principal Regulatory Operations Publisher

About the role

As a Principal Regulatory Operations Publisher, you will independently lead complex regulatory publishing projects and ensure the successful preparation and finalisation of electronic regulatory submissions. You will collaborate closely with Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams to deliver high-quality, compliant documentation.

What you'll do

• Independently lead regulatory publishing projects from planning through completion, ensuring timely and successful delivery
• Manage the finalisation, formatting, quality control, and publishing of regulatory documents for electronic submissions
• Coordinate with Medical Writing, Biostatistics, Programming, Regulatory Affairs, and other cross-functional teams to ensure submission readiness
• Independently manage major regulatory dossiers and submission amendments of varying complexity and scope
• Ensure regulatory documents comply with applicable publishing standards, technical requirements, and submission guidelines

What you need

• Compliance
• Regulatory affairs
• Clinical research
• CRO
• Documentation