Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. • Managing the registration process by providing expertise in submission regulations, guidance and technical contents. Ensure compliance with all applicable regulations and internal quality systems. • Managing regulatory submission related activities and regulatory operations, including, variations supplementary application, filing, annual report, DSUR, renewal and other projects as needed. • Managing Regulatory Information Management (RIM) Operational related activities and collaborating with GRA RD&E team to support the submission plan ‒ Understanding business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data. ‒ Handle tasks triggered by RIM processes (e.g., uploading, matching, populating document properties, archiving), improving centralized management of RIM document operations, and ensure seamless integration with other regulatory processes to avoid delays. ‒ Escalate issues to supervisor that may impact submissions and timelines ‒ Arrange Translation coordination & formatting check, ensure the accurate integration of translated documents from TransPerfect or other systems into the RIM SCP, aligning them with regulatory submission requirements. ‒ Support local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications ‒ Author administrative documents based on guidance from Regulatory scientists ‒ Compile submission dossiers according to the submission plan ‒ Execute QC testing-related activities, including material ordering, contract execution, and vendor communication etc. • Input and maintain data in China/global IT system, e.g. RIM, China submission archive and maintenance platform, 注册：进口药的中国注册

Minimum Qualification Requirements: • University/bachelor’s degree or equivalent experience is required. • Strong Communications skills are required. English language fluency is required. • Proven track record in the full lifecycle of Regulatory Operations and a minimum of 2 years of working experience in regulatory submission planning and operations in Pharmaceuticals • Good working knowledge of Document Management Systems i.e. Veeva RIM • Ability to work with various stakeholders, including Global counterparts. • Project management skills are preferred. Other Information/Additional Preferences: • Therapeutic area and product knowledge, understanding of drug development process are preferred. • Demonstrated project or submission management capabilities are preferred. • Familiarity with Industry trends and forums, FDA and/or EU, and ROW regulations & guidelines are required. • Ability to Oversee and determine daily assignments, quick response to business priorities and changing demands. • Experience with document formatting, word processing, use/applications of templates and ensuring submission readiness (i.e. bookmarking, hyperlinking and navigational aids) is preferred. • Practical understanding of evolving technologies in support of business area is preferred. • Exceptional interpersonal, teamwork, and communication skills are required. • Demonstrated ability to work effectively