Sr.RA Manager - Inflammation, Regulatory Affairs, GI&I Beijing, Beijing Municipality Category: Regulatory Affairs

Job description

Apply Now Job ID R0183063 Category Regulatory Affairs Subcategory Research & Development Business Unit Research & Development Job Type Full time 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. 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. Locations Beijing, China Worker Type Employee Worker Sub-Type Regular Time Type Full time Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more Biotech Site in Covington, GA Learn more Takeda’s Position on Climate Change Learn more Corporate Responsibility Learn more Diversity, Equity and Inclusion Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Loni's Data Science Story" data-hub-meta-title="" data-hub-meta="Explore more." data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/our-stories/all-stories/" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/rc-data-science-story.jpg" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:58" data-hub-date-created="02/26/2025 19:36:58" data-hub-date-override="08/14/2023 00