Xin Yu

Xin Yu Email and Phone Number

Vice President, PMP®
Xin Yu's Location
Chaoyang District, Beijing, China, China
Xin Yu's Contact Details

Xin Yu work email

Xin Yu personal email

n/a
About Xin Yu

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.

Xin Yu's Current Company Details

Vice President, PMP®
Xin Yu Work Experience Details
  • Alpha Biopharma
    Vice President
    Alpha Biopharma Dec 2017 - Jul 2021
    Beijing City, China
    Be 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.
  • Fresenius Kabi
    Director, Head Of Drug Innovation & Development Center
    Fresenius Kabi Jul 2013 - Dec 2016
    Wuhan, Hubei, China
    Set 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.
  • Fresenius Kabi
    Sr. Regulatory Manager/Associate Director
    Fresenius Kabi Jul 2009 - Apr 2014
    Beijing City, China
    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… 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
  • Excel Pharmastudies Inc.
    Regulatory Affairs Manager
    Excel Pharmastudies Inc. Jan 2008 - Jul 2009
    Beijing City, China
    Lead 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.
  • Roche
    Regulatory Affairs Supervisor
    Roche Feb 2007 - Dec 2007
    Beijing City, China
    Perform in import oncology product registration (IND, IMCTs & supplemental applications) and other activities; be responsible for clinical trials tissue samples exportation application.

Xin Yu Skills

Pharmaceutical Industry Regulatory Affairs Oncology Gmp Clinical Trials Cross Functional Team Leadership Project Management Strategy Regulatory Submissions Ectd Process Improvement Change Management

Xin Yu Education Details

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.

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