Leading eCTD implementation. Developing new process and tool to meet new regulation request. Ensuring well compliance for high quality RA submission. Develop and manage archiving and tracking system and other RA foundation work. Lead regulatory intelligence and competitors information collection, tracking and analysis. Build RA relevant regulations pool to support TA projects submission strategy making and planning. RA team budget management. SOP/WI developing and training.

Regulatory Operations Team Lead Basic Function:Manage and ensure regulatory processes, training and quality insurance to support China Regulatory performance improvement.Primary Responsibilities include:1. Regulatory Affairs Process Control:Identify the needs for best practices, processes, SOPs, tools, training sessions and designs relevant activities.2. Compliance and Training:Ensure full compliance with SOPs; Create New SOP/LWI and/or revise available SOP/LWI;Coordinate CAPA and QIP(Quality Improve Plan);Develop RA staff’s training needs and drive training sessions under analysis and identification. 3. Planning and RA Info. Tracking Management:Ensure RA registration planning and information is systemically tracked and timely updated.4. Archiving and Record Management:All registration documents and correspondence documents are well archived and stored.

2008/05 ~2011/09: Regulatory Operations ChinaBasic Function:1. Manage and ensure regulatory processes to support China & AP Regulatory 2. Assistant Global RO Head and PDY RA Head to develop/integrate regulatory tools/processes.Primary Responsibilities include: 1. Supervises the daily activities (tracking, compliance, archiving, planning, tools management, training and etc.) of Regulatory Operations.2. Performs major responsibilities of Regulatory Operations China as time permits.3. Global tools/processes integration and implementation, new tools design and development.4. Identifies the need for standard practices, training sessions, SOPs and designs relevant activities.5. Independently prepares budget and staffing requirements for RA/RO team6. Recruits new employees7. Coaching and supervises team members for performance and growthAchievement: 1. New RA archiving process and tools development.2. New RA Registration Info. Tracking system design and development.3. New RA Registration Documents Quality Control process creation.4. Integrate and roll out new RA FTE Management tools.5. Integrate and roll out new RA documents creation, revision, finalization and publishing tool (RAPID system) in China. 2005/10~2008/04: Regulatory Affairs (Oncology 1 Team Leader)Basic Function:1. Develop Regulatory strategy in the designated product group.2. Oversee the execution process to obtain regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group3. Develop a highly reliable and professional profile and process for Roche China

1. In charge of Registration of NDA, CTA, License Renewal, Variation applications.2. In charge of Registration of Import Cosmetics, Import Medical Device, Import Healthcare Product, Import Disinfectant application.3. Review old registration strategy and revise according to the new request from Marketing Department. 4. Building good relationship with Health Authorities such like SFDA, CDE, NICPBP and etc. 5. Supporting sales and marketing department. 6. Training juniors in registration affairs.

1. In charge of Registration of NDA, CTA, License Renewal, Variation applications.2. Building good relationship with Health Authorities such like SFDA, CDE, NICPBP and etc. 3. Supporting sales and marketing department.

1. In charge of Registration of NDA, CTA, License Renewal, Variation application2. Developing registration strategy and action plan with team leader. 3. Building good relationship with Health Authorities such like SFDA, CDE, NICPBP and etc. 4. Supporting sales and marketing department.

1. In charge of Registration of NDA, CTA, Local Manufacturer Product, License Renewal, Variation application2. Developing registration strategy and action plan with team leader. 3. Building good relationship with Health Authorities such like SFDA, CDE, NICPBP and etc. 4. Supporting sales and marketing department.

1. In charge of management of pharmacy store. 2. Cooperate with physicians to support Clinical Research in hospital.