Senior Manager, Regulatory Publishing

🔥 3 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• 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

• 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

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