Xin Yu work email
- Valid
Xin Yu personal email
Accumulated sound and dynamic experience in Novel/Generic drugs development when working in health authority / CRO/ pharmaceuticals industry over the past 17 years. In-depth knowledge of China regulations pertaining to pharmaceutical products. Familiar with ICH guidelines.When working for a Fortune Top 500 company, established the first drug innovation & development center in China from ground zero, complying to global standard.
-
Vice PresidentAlpha Biopharma Dec 2017 - Jul 2021Beijing City, ChinaBe responsible for R&D, Project Management, Regulatory Affairs and etc. for novel drugs development.Set up and implement strategic registration plan along with the project development plan in Asian countries. -
Director, Head Of Drug Innovation & Development CenterFresenius Kabi Jul 2013 - Dec 2016Wuhan, Hubei, ChinaSet up Fresenius Kabi China Drug Innovation & Development Center from ground zero. Directly report to the Head of Innovation & Development, non US and directly manage Formulation Development, Analytical Development, Requlatory Affairs, Quality Assurance, Finance Control and Project Management. Prepare forecast and budget plan and get approval. Expenses management per approved budget. Coordinate with all relevant contributors to bring more new drug products for local market. -
Sr. Regulatory Manager/Associate DirectorFresenius Kabi Jul 2009 - Apr 2014Beijing City, ChinaLead and manage Oncology & IV Drugs Team, responsible for the import products registration in China. Operate and supervise the project of import oncology drugs localization. Develop and maintain rapport with health authorities. Support BD department on license in products and work with different functional teams to resolve various issues. Innolve the "China to China" strategy development.Worked as the Acting Head for the establishment of Drug Innovation & Development Center since July… Show more Lead and manage Oncology & IV Drugs Team, responsible for the import products registration in China. Operate and supervise the project of import oncology drugs localization. Develop and maintain rapport with health authorities. Support BD department on license in products and work with different functional teams to resolve various issues. Innolve the "China to China" strategy development.Worked as the Acting Head for the establishment of Drug Innovation & Development Center since July 2013. Show less -
Regulatory Affairs ManagerExcel Pharmastudies Inc. Jan 2008 - Jul 2009Beijing City, ChinaLead and manage Consulting & Strategy Team, be responsible for various applications: IND, NDA/BLA, IMCT and variation application; contribute to the development and implementation of regulatory strategy for specific projects (New Chemical Entity), including identifying and assessing regulatory risks.
-
Regulatory Affairs SupervisorRoche Feb 2007 - Dec 2007Beijing City, ChinaPerform in import oncology product registration (IND, IMCTs & supplemental applications) and other activities; be responsible for clinical trials tissue samples exportation application.
Xin Yu Skills
Xin Yu Education Details
-
Pharmaceutical Chemistry -
Pharmacy, Pharmaceutical Sciences, And Administration
Frequently Asked Questions about Xin Yu
What is Xin Yu's role at the current company?
Xin Yu's current role is Vice President, PMP®.
What is Xin Yu's email address?
Xin Yu's email address is xi****@****abi.com
What schools did Xin Yu attend?
Xin Yu attended Shenyang Pharmaceutical University, Shenyang Pharmaceutical University.
What skills is Xin Yu known for?
Xin Yu has skills like Pharmaceutical Industry, Regulatory Affairs, Oncology, Gmp, Clinical Trials, Cross Functional Team Leadership, Project Management, Strategy, Regulatory Submissions, Ectd, Process Improvement, Change Management.
Not the Xin Yu you were looking for?
-
2gmail.com, unity.de
2 +492955XXXX
-
2 +160726XXXXX
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial