岗位职责：

1.Veeva Vault Support and eCTD management

•Create and maintain regulatory binders and document templates in Veeva Vault (e.g. submission binders, HA correspondence binders, lifecycle binders) in line with defined naming conventions, metadata standards and folder structures.

•Manage Veeva workflows end-to-end: initiate, route, monitor and close workflows; follow up with assignees to meet agreed timelines; troubleshoot routing, permission and status issues and escalate to the system owner where required.

•Support archiving regulatory files, including health authority (HA) communications, Information Requests (IRs), approval documents and other correspondence, ensuring complete, traceable and inspection-ready records.

•Perform any other Veeva-related operational tasks as assigned, including user access requests, metadata correction, document versioning, bulk upload / hyperlink checks, report generation and data quality clean-up.

•Manage eCTD compilation, QC and lifecycle maintenance for CMC documents, from sequence build and validation through post-submission updates and archiving.

2. Document Formatting and Style Check

•Apply company and submission-ready formatting to regulatory documents: template application, styles, headings, table of contents, cross-references, numbering, headers/footers, bookmarks and hyperlinks.

•Execute style checks against internal authoring standards and, where applicable, eCTD / HA formatting requirements; correct deviations and return clean, version-controlled files to authors.

3. Quality Control (QC) Check

•Perform pre- and post-formatting QC of regulatory documents, checking completeness, internal consistency, version and reference accuracy, hyperlink integrity, and conformance to the document checklist.

•Document QC findings, track resolution and confirm closure before the document is released into review, approval or submission.

4. Consolidation of Review Comments

•Collect, de-duplicate and consolidate review comments from multiple reviewers into a single Comment Resolution Sheet (CRS).

•Track the status of each comment (accepted / rejected / pending clarification), support reviewers and authors through resolution, and maintain the audit trail of decisions.

5.  On-Boarding Support for New Hires

•Support the on-boarding of new team members: system access set-up, Veeva Vault orientation, walkthrough of SOPs, templates, workflows, meeting logistics, and point-of-contact support during the ramp-up period.

•Maintain and refresh on-boarding materials and quick-reference guides so that process knowledge is transferred consistently.

6. General Affairs per the Region needs

•Provide general administrative and coordination support for the region: organize team and cross-functional meetings (scheduling, agenda and material collection, room / virtual meeting set-up), take and distribute minutes, and track follow-up of action items to closure, regulatory intelligence support (conference participation information, external industrial activities), portal management (maintenance of files uploading and archiving).

•Own local document management for the region: maintain local shared drives, ensure documents are stored, version-controlled and retained in line with local SOPs, records management and data integrity requirements, and support retrieval of documents for inspections, audits and internal reviews.

•Support day-to-day regional team operations, including coordination of local training sessions and team events, vendor / purchase request and invoice follow-up, and other ad-hoc general affairs tasks required to keep Regulatory Affairs CMC activities in the region running smoothly.

资历要求：

•Fresh graduate with excellent track record in study performance or  1~2 years’ experiences in Regulatory Operation, regulatory affairs, CMC documentation or submission publishing within the pharmaceutical / biopharmaceutical industry.

•Hands-on working experience with Veeva Vault (RIM, RegDocs / eDocs, Submissions or Authoring) is preferred; experience with other regulatory information management or document management systems is an advantage.

•Working knowledge of eCTD structure, CTD Module organization and CMC dossier content is strongly preferred.