Summary of Job Responsibilities: (Please use 2 to 3 sentences to summarize the purpose of the job.) 1. Support regulatory submission activities for assigned projects across TAs 2. Execute regulatory strategy plans to support successful LCM of responsible marketed products 3. Support timely Regulatory filings and response to HA queries 4. Support related operation activities for post approval project management 5. Establish relationship with HA and collaborate with key stakeholders in the local, regional and global organization Dimensions of Job: (Please provide quantitative indicators on which the job has impact – e.g., earnings, revenue, budget, staffing, etc. Include indicator that best represents the main purpose of Job.) 1. Regulatory support for responsible marketed products 2. Work with key stakeholders including TA product owners, JJRO, RSI, Translation center etc. 3. Liaise with Regulatory agency Principal Accountabilities of Job: (Please list 6 to 8 major responsibilities/objectives of the job in order of importance.) 1. Collaborate with global, regional and local product teams to develop and implement registration plan and regulatory strategy for post approval products. 2. Execute regulatory activities & review critical submissions for assigned projects, and conduct QC testing and customs clearance activities as the requirements for post approval products. 3. Support timely Regulatory submission and team response efforts to HA request. 4. Coordinate internal discussion to revision of regulations, guidelines if applicable. 5. Develop internal regulatory process for effective operation. 6. Credo based behavior with regulatory compliance excellence. Key Performance Measures: (Please list the key performance measures of this job) 1. Effectively set regulatory strategy 2. Timely delivery of regulatory submissions with high quality 3. Keep compliant with SOP/WI/Job-aids and local regulations. 4. Good communication and leadership 5. Others: Strategic thinking, Cross-functional collaboration; Crisis management

Qualifications & Competencies: (Please list competencies in order of importance, including languages) 1. Bachelor or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred. 2. Experience in a multinational pharmaceutical company is preferred. 3. Strong oral & written communication skill; ability to work under pressure. 4. In-depth knowledge of regulatory environment, regulations and guidelines. 5. Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization. 6. Proficiency in verbal and written English; good computer skill, good presentation skill.