职位描述
JOB SUMMARY
The CTRSE Regional Submission Manager, is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials, across multiple TAs, Phases and Markets. The CT RSM Provides an interface to GSSO partners, offering project leadership and expertise in the strategic and operational execution of regulatory Clinical Trial Application (CTA) submissions to regional partners and selected Health Authorities/Central Ethics Committees. This role will focus on the CTA submissions in China and other APAC countries.
The Clinical Trial Submission Manager (CT-SM) is accountable for working with contributing business lines to lead submissions execution timelines for designated CTAs. They may operate as regulatory Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CT-SM is required to author