Jenny Zha

Proficient with Veeva BRIM and Veeva Quality for • Regulatory document lifecycle management, e.g. IMPD creation and redline version, version tracking • Health authority question and commitment: data analysis and projection • create dossiers for country specific submissions, including initial IND, IND amendment (tech transfer), BLA and PAS • start workflow for dossier review, approval, Health Authority IR request • use submission content plan for eCTD/non-eCTD submissions. • change control/change action management (VV Quality） Regulatory CMC strategy and Health Authority consultation Great presentation skills / cross-functional collaboration skills

• Develop regulatory strategy for new product global registration We provide interpretive assistance of relevant guidance documents to facilitate decision making process. We work closely with cross-functional teams to make/adjust regulatory strategy for new product launch/product renewal. ● Compiled/reviewed 510(k) submission package and drafted MDD/MDR CER for medical devices Side by side comparison of product specifications is performed between new product and the predicate device. • Perform global registration for medical devices Following 510(k) submission, I collect/draft the registration documents, e.g. product specification, post market surveillance plan and biocompatibility reports, etc, based on 510(k) and CE technical file. Once we obtain 510(k) clearance from FDA, all the documents would be released for global registration. • Facilitate MDD to MDR transition We work closely with production to make sure all the safety and performance requirements are met from design input to design validation. • Answer Additional Information Requests from authorities; fully communicate with engineer/vendors for additional tests/reports for submission approval. I host periodic meetings to communicate the AI requests from different jurisdictions to production (PD). When PD doesn’t have enough resource to perform the required tests, I would manage to provide convincing rationale for the authorities to defend our decision. • Perform good documentation practice Color coded excel sheets are employed to help me keep track on document status (in process/obtained/submitted) for each medical device. I need to manage concurrent multiple regulatory submissions from different jurisdictions.

• Help CRO communicating with hospitals and clinical testing centers overseas 2019-Now • Focus on documents of Cancer treatment, Next Generation Sequencing-based platform, immune testing panels, cardiovascular medical devices, etc

• Develop QC method and write SOP • Date and count received products from the manufacture, disposition inventory based upon QC status • Performed method comparison study, collected data for 510(k) of IVF medical devices • Calibrate equipment and keep maintenance logs • Assure regulatory documents are completed and signed for each project • Help with final release process for finished package goods • Prepare data package for FDA audit • Train new employee on GMP

Study the interaction between human mesangial cell and mesanchymal stem cell under renal pathogenesis conditions: Imaging: Fluorescent microscope, Zeiss 6 dimensional live cell imaging system Cell culture: human mesangial cell, mouse mesangial cell, mesenchymal stem cell Immunohistochemistry: pre/post-embedding Immunogold staining Molecular biology: western, PCR, etc Lab management

• Developed 4 different functional assays to test the potency for candidate monoclonal antibodies (mAb). More than 9000 mAb samples were successfully screened within 3 weeks. • Optimized the testing method for in-house antibody qualification before animal studies. • Collaborate with QC for analytical testing: lot release QC/stability testing • Interpreted scientific data gathered: Two peer reviewed journal papers were published. Data analysis and presentation: • Analyze the data with multiple softwares: SoftMax, Excel, Flow Jo, Prism, etc. • Present data on department meetings Director’s Award of Medimmune /AstraZeneca, LLC 2012, 2013

Compliance with GCLP (Good Clinical Laboratory Procedure) guidelines: • Performed clinical sample processing, In Vitro testing and data analysis for vaccine trials (Malaria, HIV, etc.). Prepared data packages for FDA audit for each clinical time point to record different patient response. • Wrote/finalized SOP for newly developed procedure in great details • Investigated out-of-specification results; prepare QC reports, deviation reports, etc. • Record sample specification (color and clearance for serum samples, cell number for PBMC samples) in LIMS Perform immunological testing and analysis on serum/plasma/PBMC samples: • ELISpot, ELISA and Intracellular Cytokine Staining • Analyze raw data with SoftMax and Excel, prepare data package

Dept. of Microbiology and Immunology Viral immunology Flow Cytometry Center Murine disease model

Genetics Cytokine Secretion Molecular Biology Oncology