Experience

Shanghai Zerun Biotechnology Co.,Ltd.

• China
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Supervisor

  • Apr 2020 - Present

  -Responsible for the communication with NMPA, CDE, CFDI, ChP committee as well internal between manufacture and group corporations. -Manufacture site regulatory affairs. -And support for CMC inspection, and lead 2 clinical sites inspection and iusses to clarification.

• Regulatory Affairs Specialist

  • May 2019 - Mar 2020

  - Lead one Biologic License Application as well as Pre-BLA meeting, review all documents, and draft overall summary documents（CMC & Nonclinical) and clinical support - Handle WHO pre-qualification projects preparation including dossier and procedures.-Provide the CMC strategy before phase 3 clinical stage.－COVID 2019 vaccine IND Regulatory Affairs.-Outstanding staff award of 2019.



Humphries Pharmaceutical Consulting

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager of Regulatory Affairs

  • Jul 2017 - Apr 2019

  - Coordinate teams to prepare 3 INDs application(including Clinical, CMC, Nonclinical) as well as Pre-IND meeting. All successfully safe to proceed by FDA. -Coordinate one Phase 1 Clinical trial in U.S.-Prepare one EOP2 meeting with FDA and coordinate its phase 3 clinical design.-Complete more than 20 times electronic CTD docs preparation and submission（more than 10 times information request by FDA).-As preclinical team members, cordinate preclinical team to complete the analysis of defiencies（Not find NOAEL in general toxicology and target toxicity). Participate in 6 INDs' preclinical writing including NCE, CAR-T as well as antibodies.-Distinguished efforts award in 2018.



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Clinic Science Intern

  • Aug 2016 - Oct 2016

  As an intern, review the data of eCRF(Q&A) and make preliminary statistics about NSCLC's prospective study. As an intern, review the data of eCRF(Q&A) and make preliminary statistics about NSCLC's prospective study.



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Marketing Intern

  • Jan 2015 - Jun 2015

  Questionnaire input and analysis. Questionnaire input and analysis.