Global Regulatory Submissions Lead

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health plan

Stock options

PTO

Zusammenfassung

Cabaletta Bio, Inc. is seeking a Senior Manager, Regulatory Publishing to lead the preparation, publishing, validation, and transmission of electronic regulatory submissions at a global scale.

This role partners with Regulatory Affairs, Medical Writing, Clinical Development, and Quality to ensure timely, compliant submissions to health authorities worldwide. The ideal candidate has 5+ years in regulatory publishing with advanced eCTD skills and hands-on experience with Veeva Publishing,

Qualifikationen

• 5+ years Regulatory Publishing experience (Submissions and Report Level Documents)
• Advanced eCTD publishing expertise
• Experience with Veeva Publishing, Submission Archive, and validation tools
• Recent hands-on experience publishing and validating eCTD submissions
• Strong knowledge of regional submission requirements
• Experience supporting global submissions across multiple health authorities
• Experience in both investigational and marketing applications preferred

Aufgaben

• Publish and validate electronic regulatory submissions in eCTD and regional electronic formats
• Manage submission assembly, lifecycle operations, hyperlinking, bookmarks, metadata, and technical validation activities
• Perform quality control reviews of published submissions
• Generate and review validation reports and resolve technical publishing issues
• Maintain submission archives and ensure inspection-ready records
• Support continuous publishing workflows within Veeva RIM and Submission Archive environments
• Collaborate with authors to ensure documents meet publishing standards and technical requirements
• Manage lifecycle operators and sequence management activities
• Support gateway transmissions and acknowledgement processing
• Develop publishing standards, templates, and best practices
• Identify opportunities to automate publishing and validation processes
• Collaborate with external vendors to ensure submission publishing efficiency for applications externally published

Kenntnisse

Regulatory publishing

eCTD publishing

Global submissions

Cross-functional collaboration

Tools

RIM Vault Publishing

eValidators

DXC Toolbox

MS Office

Jobbeschreibung

Cabaletta Bio, Inc. is seeking a Senior Manager, Regulatory Publishing to lead the preparation, publishing, validation, and transmission of electronic regulatory submissions at a global scale.

This role partners with Regulatory Affairs, Medical Writing, Clinical Development, and Quality to ensure timely, compliant submissions to health authorities worldwide. The ideal candidate has 5+ years in regulatory publishing with advanced eCTD skills and hands-on experience with Veeva Publishing,