Senior Manager, Regulatory Affairs, GI&I

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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.

R&D Qualifications & Skills 

• Level of Education: Bachelor’s degree or above majored in medicine or pharmacy.
• Working Experience in Relevant Field: >7 years related work experience
• Professional Knowledge and Skills: Skilled in using computer office software. Good English or Japanese in listening, speaking, reading and writing. Be familiar with the laws and regulations of drug administration and registration management, stronger professional competency, excellent communication skill and leadership. Teamwork and collaboration. 

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