Senior Regulatory Affairs Publisher Consultant

📋 Description

• Prepare, format, QC, and publish regulatory documents for global authorities.
• Publish in eCTD format and ensure on-time submissions.
• Coordinate submission timelines with RA teams and stakeholders.
• Submit dossiers to FDA, EMA, Health Canada via gateways.
• Maintain submission archives and document management in systems.
• Support lifecycle activities (amendments, variations, renewals).
• Ensure adherence to SOPs and regulatory standards.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related.
• 2–5+ years in regulatory publishing/operations.
• Experience with eCTD publishing and submission processes.
• Knowledge of eCTD structure and global submission requirements.
• Experience with Lorenz docuBridge, Extedo eCTDmanager, GlobalSubmit.
• Familiarity with Veeva or SharePoint document management.