Senior Manager, Regulatory Publishing

Cabaletta Bio

. Prepare, publish, validate, and transmit electronic regulatory submissions supporting global development and commercial programs .

Posted 10/16/2026full-timeRemote • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates advanced expertise in eCTD publishing and regulatory submissions, with a strong focus on quality control, technical validation, and collaboration with cross-functional teams. Proven ability to develop publishing standards and improve processes within Veeva RIM and Submission Archive environments.

Highest-signal resume keywords

Regulatory Publishing ExperienceAdvanced eCTD Publishing ExpertiseVeeva Publishing ExperienceStrong Knowledge of Regional Submission RequirementsTechnical Validation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ECTD PublishingSubmission AssemblyQuality Control ReviewsTechnical ValidationLifecycle ManagementPublishing Standards DevelopmentAutomation of Publishing ProcessesSubmission DeliveryTroubleshootingMetadata Management

Soft Skills

Attention to DetailProblem-Solving SkillsCommitment to Operational ExcellenceCollaborationMentoring

Tools & Technologies

Veeva RIMSubmission ArchiveAdobe PDFEValidatorsDXC ToolboxMS OfficeSmartSheet

Industry Keywords

Global SubmissionsHealth AuthoritiesInvestigational ApplicationsMarketing ApplicationsPublishing Efficiency

Tech Stack

Tools & technologies

AssemblyVault

About the role

Key responsibilities & impact

Prepare, publish, validate, and transmit electronic regulatory submissions supporting global development and commercial programs
Publish and validate submissions in eCTD and regional electronic formats
Manage submission assembly, lifecycle operations, hyperlinking, bookmarks, metadata, and technical validation
Perform quality control reviews of published submissions
Generate and review validation reports and resolve technical publishing issues
Maintain submission archives and inspection-ready records
Support continuous publishing workflows within Veeva RIM and Submission Archive environments
Collaborate with authors and cross-functional stakeholders 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 improve submission publishing efficiency
Participate hands-on in publishing, validation, lifecycle management, troubleshooting, and submission delivery
Mentor others and contribute to process improvements

Requirements

What you’ll need

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 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
Knowledge of Veeva RIM, RIM Vault Publishing, Adobe PDF, eValidators, DXC Toolbox, and MS Office (Outlook, PowerPoint, Excel, SmartSheet)
Strong technical expertise, attention to detail, problem-solving skills, and commitment to operational excellence
Authorization to work in the United States is requested in the application
Ability to address future employment visa sponsorship requirements in the application

Benefits

Comp & perks

Competitive benefits
PTO
Stock option plans
Opportunities to mentor others
Opportunities to contribute to process improvements