洋 卢
Submission/Archivist Associate Manager, Submission Operations Management, Regulatory Operations @ BeOne Medicines
China
Chaoyang District
Biotechnology
First Aid, Mandarin, ACE Certified Personal Trainer, Archiving, Coordinating Meetings, Submittals, Computer Literacy, Responsiveness, Archival Processing, Fleet Management, Information Technology, Corporate Advisory, Database Maintenance, Humility, Writing, Organization Skills, Electronic Common Technical Document (eCTD), Submission Publishing, Business English, Microsoft Office
Experience

Submission/Archivist Associate Manager, Submission Operations Management, Regulatory Operations
Beijing, China
1. Responsible for document archiving work in APAC countries, ensuring that documents are archived correctly, timely and easily accessible for subsequent inquiries. 2. Maintain the application work for confidential documents, and coordinate and communicate well between RA leaders and colleagues from various departments. 3. Responsible for the publishing of documents submitted to HA in China & APAC, and deliver high-quality registration documents. 4. Provide regular training to help relevant colleagues understand the archiving and submission processes. 5. Test various software of CDE, and assist colleagues in other regions with coordinating work such as printing, disc burning and signing. 6. Communicate with relevant departments in a timely manner regarding issues arising during the registration process to ensure smooth submission.

Associate Manager
BeiGene (BeOne) Company Ltd.
1. Responsible for document archiving work in APAC countries, ensuring that documents are archived correctly, timely and easily accessible for subsequent inquiries. 2. Maintain the application work for confidential documents, and coordinate and communicate well between RA leaders and colleagues from various departments. 3. Responsible for the publishing of documents submitted to HA in China & APAC, and deliver high-quality registration documents. 4. Provide regular training to help relevant colleagues understand the archiving and submission processes. 5. Test various software of CDE, and assist colleagues in other regions with coordinating work such as printing, disc burning and signing. 6. Communicate with relevant departments in a timely manner regarding issues arising during the registration process to ensure smooth submission.

Specialist
Bayer Healthcare Company Ltd. (Fortune 500)
1. Responsible for the optimization, naming and uploading of the literature work for section 4.3 and 5.4 worldwide to meet the requirements of the agencies; 2. Trained new employees in understanding the basic knowledge of eCTD submission; 3. According to actual condition, actively produced and maintained literature SOP; 4. eCTD submission & lifecycle management of EU consumer heath & AU pharmacy; 5. Got knowledge of various submission types such as ICTD/ACTD/NeeS, and assisted relevant colleagues in handling NDA QC.

eCTD Submission Specialist, Regulatory Submission Management, Regulatory Affairs Operations
Bayer Healthcare Company Ltd.
Beijing, China
1. Responsible for the optimization, naming and uploading of the literature work for section 4.3 and 5.4 worldwide to meet the requirements of the agencies; 2. Trained new employees in understanding the basic knowledge of eCTD submission; 3. According to actual condition, actively produced and maintained literature SOP; 4. eCTD submission & lifecycle management of EU consumer heath & AU pharmacy; 5. Got knowledge of various submission types such as ICTD/ACTD/NeeS, and assisted relevant colleagues in handling NDA QC.

Administrative Support Specialist
KPMG corporate advisory management Ltd. (big four accounting firm)
1. Responsible for the reservation and coordination of important meeting rooms; 2. Responsible for vehicle coordination and management; 3. Maintain and update admin related forms and data.

Admin support
KPMG corporate advisory management Ltd.
Beijing, China
1. Responsible for the reservation and coordination of important meeting rooms; 2. Responsible for vehicle coordination and management; 3. Maintain and update admin related forms and data.
Education

International Economics and Trade
Rank: Strong learning ability and self descipline, with excellent academic performance, ranking 1/46 in the major, GPA 3.74/4, weighted average score 92/100. Political status: CPC member, from Nov. 2016. Position: Deputy secretary of the party branch of the major; Counselor assistant.
洋 卢's Contact Information
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