Position Summary Prepare China eCTD and eSubmission dossiers and ensure submissions are technically compliant with China health authority requirements and standards. Key Responsibilities Format and publish electronic regulatory dossiers for China health authorities. This role serves as a critical link between global and local Regulatory Affairs teams, ensuring that submissions are technically valid, compliant with China eCTD/eSubmission specifications, and delivered on time. Major tasks include:  Document formatting: Convert Word, PDF, and other source files into Health Authority– compliant PDFswith appropriate bookmarks, hyperlinks, and document properties.  eCTD/eSubmission compilation: Build eCTD sequences and eSubmissions in publishing software, including document assembly, cross-document hyperlinking,metadata, and required attributes.  eCTD lifecyclemanagement: Manage lifecycle publishing activities for all submission types, including but not limited to NDAs, CTAs, variations, and protocol amendments.  Quality control: Reviewcompiled submissions against source documents and applicable checklists.  Technical validation: Run validation software and resolve technical issues before submission transmission.

Bachelor’ s degree or higher in Life Sciences, Information Technology, or a related field, with 3– 5 years of pharmaceutical industry experience.  Experience in eCTD publishing and Regulatory InformationManagement systems (e.g., Veeva Vault RIM). Advanced proficiency in at least onemajor eCTD publishing system, e.g., Veeva Publishing, Lorenz DocuBridge. etc.  Experience with China eCTD/eSubmission is preferred; knowledge of eCTD 4.0 is a plus.  Advanced skills in MicrosoftWord and Adobe Acrobat.  Strong communication skills and the ability to explain complex technical requirements to non-technical stakeholders.  Demonstrates strong accountability and collaboration by reliably owning deliverables and working proactivelywith cross-functional teams to achieve shared objectives.  Fluent in written and spoken English.