Regulatory Publishing Specialist

Job Summary

Working remotely on a contract basis, the Regulatory Publishing Specialist will manage U.S. FDA and select EU regulatory submission projects, ensuring compliance with global regulatory requirements while overseeing submission preparation, publishing, and archival activities.

Key responsibilities

• Lead regulatory submission projects in partnership with Regulatory Affairs teams
• Manage submission preparation, publishing, transmission, and archival activities according to internal procedures
• Provide guidance on regional and technical submission requirements while serving as a subject matter expert

Required qualifications

• Bachelor's degree in Life Sciences or a related field
• 3+ years of Regulatory Operations experience within the pharmaceutical or biotechnology industry
• Experience preparing and managing regulatory submissions that have achieved first-pass technical acceptance
• Knowledge of FDA, EMA, and ICH regulatory requirements and submission guidelines
• Experience with electronic regulatory submission formats, including eCTD and SPL