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. 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. Qualifications: