Senior Manager, RA, GI&I

Description

In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration leading to minimal registration timeline. May lead a project team or initiative within department or cross-functions/divisions. Provides technical leadership to business. Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide corresponding support for the sales in China market. In accordance with the plan of product registration and application for approval, manage the necessary materials and information during the process and track and summarize the progress. Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of raw data review and on-site assessment. Manage and arc...