Senior Manager, Regulatory Publishing

Senior Manager, Regulatory Publishing

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

Senior Manager, Regulatory Publishing

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.

Expectations:

• 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.

Experience:

• 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:

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

The successful candidate will be a highly experienced, hands-on regulatory publishing professional who enjoys technical execution and operational excellence. This role requires active participation in publishing, validation, lifecycle management, troubleshooting, and submission delivery activities. This is a highly collaborative individual contributor role requiring strong technical expertise, attention to detail, problem-solving skills, and a commitment to operational excellence. The position is not primarily a people-manager, however opportunities to mentor others and contribute to process improvements are interwoven into the role.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

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

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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-REMOTE