Senior Manager, China CMC Regulatory Affairs Shanghai, Shanghai Municipality Category: Regulatory Affairs

Job description

Job Posting Find jobs for Location Radius Senior Manager, China CMC Regulatory Affairs Shanghai, Shanghai Municipality Apply Now Job ID R0193265 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 With minimal supervision, plans, executes and manages regulatory submission for assigned compounds in various phases of clinical development, marketing applications, and post -approval life cycle activities. As a RA CMC products leader or member, ensure and/or enhance regulatory compliance with respect to filling requirements for assigned compounds throughout development and the commercial life cycle. · Independently prepare CMC submission dossier, define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement. · With moderate supervision, represent Takeda RA CMC Health Authority meetings and leads or supports CMC preparation activities for meeting with Health Authority on CMC relevant matters, interacts directly with Health Authorities, as required. · With minimal supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval. · With moderate supervision, support Health Authority on-site inspection on CMC RA related matters. · Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in professional and timely manner. · Foster constructive working relationships when interacting with internal or external colleagues. · Evaluates change proposals for regulatory impact. And plans global variations and amendments. Ensure compliance with all applicable Takeda SOPs, and local and international regulations. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: · BS/BA Degree required with 6+ years of relevant Industry, academic or HA experience; advanced degree preferred · Experience with CMC regulatory and regulatory, or equivalent industry experience. · Understanding of scientific principles and regulatory requirements relevant to drug development and post-market support. · Proven ability to provide strategic regulatory guidance to drug development, registration and post market support teams. · Able to deal with issue of critical importance with minimal supervision, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. · Demonstrated emerging leadership, problem-solving ability, flexibility and team work. · Exercises good judgement in elevating and communicating actual or potential issues to line management. · Excellent written and oral communication skills required. · Active participation in Agency/ industry groups/forums preferred. Locations CHN - Shanghai - Research and Development 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 <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="Corporate Responsibility" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/corporate-responsibility/" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_corporate_responsibility.png" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:55" data-hub-date-created="02/26/2025 19:36:55" data-hub-date-override