Senior Regulatory Publishing Lead (Remote)

Cabaletta Bio, Inc.; Ohio; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock options

Job summary

Cabaletta Bio is seeking a Senior Manager, Regulatory Publishing to lead electronic submissions for global development and commercialization programs. This role partners with Regulatory Affairs, Medical Writing, Clinical Development, Quality, and cross-functional stakeholders to ensure timely, compliant submissions to health authorities worldwide.

The ideal candidate has 5+ years in regulatory publishing, advanced eCTD skills, and hands-on experience with Veeva Publishing and Submission Archive.

Qualifications

• 5+ years Regulatory Publishing experience.
• Advanced eCTD publishing expertise.
• Experience with Veeva Publishing, Submission Archive, and validation tools.
• 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

Veeva Publishing

Submission Archive

Global submissions

Quality control

Tools

RIM Vault Publishing

eValidators

DXC Toolbox

MS Office

Job description

Cabaletta Bio is seeking a Senior Manager, Regulatory Publishing to lead electronic submissions for global development and commercialization programs. This role partners with Regulatory Affairs, Medical Writing, Clinical Development, Quality, and cross-functional stakeholders to ensure timely, compliant submissions to health authorities worldwide.

The ideal candidate has 5+ years in regulatory publishing, advanced eCTD skills, and hands-on experience with Veeva Publishing and Submission Archive.