Senior Manager, Regulatory Affairs, Onco

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Accountabilities:

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 archive examination and registration materials and other relevant documents.Provide necessary support to the preparation and implementation of clinical trial.Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NIFDC, PIDC etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products etc.Establish and maintain internal/external channels of communication.Ensure regulatory activity is in compliance with authority and Takeda policy.Coordinate with the establishment of internal SOP and system.Others assigned by line manager.