洋 卢

Submission/Archivist Associate Manager, Submission Operations Management, Regulatory Operations @ BeOne Medicines

Country

China

City

Chaoyang District

Industry

Biotechnology

Skill

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

BeOne Medicines

Submission/Archivist Associate Manager, Submission Operations Management, Regulatory Operations

BeOne Medicines

LinkedIn
2022-4 - Present · 4 yrs 6 mos

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.

BeiGene (BeOne) Company Ltd.

Associate Manager

BeiGene (BeOne) Company Ltd.

2020-2 - Present · 6 yrs 8 mos

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.

Bayer Healthcare Company Ltd. (Fortune 500)

Specialist

Bayer Healthcare Company Ltd. (Fortune 500)

2020-2 - 2022-3 · 2 yrs 2 mos

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.

Bayer Healthcare Company Ltd.

eCTD Submission Specialist, Regulatory Submission Management, Regulatory Affairs Operations

Bayer Healthcare Company Ltd.

2020-1 - 2022-3 · 2 yrs 3 mos

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.

KPMG corporate advisory management Ltd. (big four accounting firm)

Administrative Support Specialist

KPMG corporate advisory management Ltd. (big four accounting firm)

2019-6 - 2020-1 · 8 mos

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.

KPMG corporate advisory management Ltd.

Admin support

KPMG corporate advisory management Ltd.

2019-7 - 2019-12 · 6 mos

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

Beijing Wuzi University

Beijing Wuzi University

LinkedIn

International economics and trade

2015-9 - 2019-7 · 3 yrs 11 mos
Beijing Wuzi University

Beijing Wuzi University

LinkedIn

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.

's Contact Information

Email

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Phone

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