Senior Manager, Global Regulatory Operations, Publisher

Key Highlights

• Responsible for the creation, assembly, and publishing of both major and routine global electronic submissions (eCTD and NeeS), including MAA, BLAs and INDs for Original Applications, DSURs, Supplements, and more.
• Serve as the global submissions’ expert, guiding teams on e-submission standards (eCTD, NeeS, etc.) and lifecycle management, while clearly communicating regional regulatory differences.
• Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to the Regulatory Users for internal review/approval.
• Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.