东莞招聘

1. Beaccountable for publishing, managing of printing and binding, dispatching thehigh quality submission dossier to Health Authorities to meet HA requirementsand company Submission target.

- Work closely with China DRA Submission Managerand Regulatory Brand team to support major submissions and Artwork preparationafter approvals, e.g. NDA, CTA and HA Q&A.

- Support China Regulatory Brand team onvariations submissions and artwork preparation after HA approval, e.g. LicenseRenewal, CMC, CDS/PI, PSUR and others.

2. Be familiar with SubmissionManagement Process, Publishing Tool and process. And facilitate team to followthe submission format of HA requirements.

3. Ensure the daily works meet IGM requirements,e.g. publishing, printing, dispatching and archiving.

4. Support the archiving of electronicsubmissions, HA correspondence, approvals in system according to SOPs/WPs.

5. Support to oversight the quality of printingvendor according to company standard.

6. Collaborate with IGM coordinator to achieveannual record management objective.

7. Support testing as Technical expert, when HA launch new related systems and tools, provide training toRA team as needed.

8. Support DRA Ops activities / initiativesad-hoc.

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