This position and role • This position is to support team work and ensure the regulatory compliance with the Good Regulatory Practice as well as to meet global and local regulatory requirements. Major Responsibilities • This role will involve working closely with RIM (Regulatory Information Management), eTMF (Electronic Trial Master File), and PLANSIWARE systems, all of which are critical in ensuring compliance and efficiency in our clinical trial and drug registration processes. • Performing routine administrative tasks • Team supporting tasks/centralized tasks Major Responsibilities and Duties: • Serve as the cornerstone of regulatory compliance, facilitating efficient information organization, retrieval, and decision-making. • Support the maintenance and updating of RIM systems, ensuring timely access to accurate and up-to-date regulatory information. • Critical for maintaining the traceability, completeness, and security of clinical trial data, essential for successful drug registration. • Collaborate in the establishment and ongoing management of eTMF, maintaining the integrity and compliance of clinical trial data. • Enhances project management efficiency by coordinating resources, tracking progress, and managing risks, ensuring clinical trials proceed smoothly. • Gain proficiency in using PLANSIWARE or similar project management systems to streamline clinical trial documentation and processes. Teamwork Spirit • Actively participate in team working Education, Qualifications • Current enrollment in Bachelor or Master’s degree, English, IT or Pharmacy related majors. Experience • Good track record; independent working; experience in drug/biologic is a plus. Skills • Chinese and English (proficiency level) • Computer skill: word, excel, power point At least 1 year availability with 4-5 days/week.