Hands-on skills in preparing regulatory document, research and analysis.Experiences in IND, clinical trial protocol and monitoring, 510(k), business plan.Familiar with FDA and CFDA policies and regulations.Proficient with Microsoft Office.Fluent in English and Chinese (Mandarin & Cantonese).Passionate and optimistic.
Shenzhen Hightide Biopharmaceutical Ltd.
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Senior Project Manager - Regulatory AffairsShenzhen Hightide Biopharmaceutical Ltd. Jul 2015 - PresentShenzhen, Guangdong, China
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Raw Material AnalystLevlad Llc Jun 2014 - May 2015Chatsworth, California
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InternU.S. Food & Drug Administration (Fda) National Center For Toxicological Research (Nctr) Jan 2014 - Apr 2014Jefferson, Arkansas• Review drug approval package to identify drugs that may cause sex-biased toxicity or adverse drug reactions• Primary culture of hepatocyte• Study the mechanism of drug-induced hepatotoxicity
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Licensing InternUsc Stevens Center For Innovation Sep 2013 - Dec 2013Los Angeles, CaliforniaTechnology assessment, market research, and new venture planning in Life Science field.• Review invention disclosures and related information submitted by USC inventors• Assess development of technology since initial disclosure • Perform market research to understand the competitive environment and evaluate potential market opportunities of each technology and their value proposition in given market• Write non‐confidential disclosure summaries (NCDs) for marketing… Show more Technology assessment, market research, and new venture planning in Life Science field.• Review invention disclosures and related information submitted by USC inventors• Assess development of technology since initial disclosure • Perform market research to understand the competitive environment and evaluate potential market opportunities of each technology and their value proposition in given market• Write non‐confidential disclosure summaries (NCDs) for marketing purposes• Identify potential commercialization/licensing partners and business contacts relevant to each technology Show less
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InternInternational Center Of Regulatory Science, Usc Sep 2012 - Nov 2013Los Angeles, California• Drafted regulatory documents, such as IDE and IND, and submitted them to FDA in a timely manner• Consulted faculty members on IDE, 510(k) product development, GLP and clinical research • Core member of a clinical trial monitoring team for a phase II clinical trial for acute stroke• Core member of an audit team for a GLP rat study• Created regulatory document templates including IND templates in eCTD format and Case Report forms • Conducted a research project on current IND… Show more • Drafted regulatory documents, such as IDE and IND, and submitted them to FDA in a timely manner• Consulted faculty members on IDE, 510(k) product development, GLP and clinical research • Core member of a clinical trial monitoring team for a phase II clinical trial for acute stroke• Core member of an audit team for a GLP rat study• Created regulatory document templates including IND templates in eCTD format and Case Report forms • Conducted a research project on current IND registration in China Show less
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Regulatory Affairs Cmc InternShire Pharmaceuticals Jun 2013 - Aug 2013Lexington, Massachusetts• Manage database of regulatory agency questions and response approach, with a focus on quality related topics.• Maintain records for Certificate of Analysis of investigational and market products
Liming Xie, Ms, Pmp Skills
Liming Xie, Ms, Pmp Education Details
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Biotechnology -
The Affiliated High School Of South China Normal UniversityPhysics
Frequently Asked Questions about Liming Xie, Ms, Pmp
What company does Liming Xie, Ms, Pmp work for?
Liming Xie, Ms, Pmp works for Shenzhen Hightide Biopharmaceutical Ltd.
What is Liming Xie, Ms, Pmp's role at the current company?
Liming Xie, Ms, Pmp's current role is Senior Project Manager at HighTide Therapeutics.
What schools did Liming Xie, Ms, Pmp attend?
Liming Xie, Ms, Pmp attended University Of Southern California, Sun Yat-Sen University, The University Of Hong Kong, The Affiliated High School Of South China Normal University.
What are some of Liming Xie, Ms, Pmp's interests?
Liming Xie, Ms, Pmp has interest in Social Services, Table Tennis, Badminton, Education, Playing The Piano, Science And Technology.
What skills is Liming Xie, Ms, Pmp known for?
Liming Xie, Ms, Pmp has skills like Pharmaceutics, Drug Development, Clinical Research, Research, Biotechnology, Lifesciences, Regulatory Affairs, Sds Page, Molecular Biology, Biochemistry, Elisa, Gmp.
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