Senior Manager, Regulatory Publishing

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health plan

Stock options

PTO

Job summary

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,

Qualifications

• 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

Responsibilities

• 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

Skills

Regulatory publishing

eCTD publishing

Global submissions

Cross-functional collaboration

Tools

RIM Vault Publishing

eValidators

DXC Toolbox

MS Office

Job description

The Senior Manager, Regulatory Publishing role is responsible for the preparation, publishing, validation, and transmission of electronic regulatory submissions in support of global development and commercial programs. This role serves as a key member of the Regulatory Operations team, partnering closely with Regulatory Affairs, Medical Writing, Clinical Development, Quality, and cross-functional stakeholders to ensure timely, compliant, and high-quality submissions to health authorities worldwide.

Responsibilities Include

• 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.

Required Qualifications

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

Tool Knowledge:

• RIM Vault Publishing
• eValidators
• DXC Toolbox
• MS Office (Outlook, PowerPoint, Excel, SmartSheet)

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.