Yu Zhang

Experience

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  Danone

  Mar 2018 - Sept 2018

  Probiotic intern

  - Self-studied the lecture of Nutrition and Health: Human Microbiome within one week; independently designed protocol to unravel the interaction between different short-chain fatty acids, different species of Bifidobacterium, and pathogens, indicating that 2-Fucosyllactose might stimulate the growth of certain species of Bifidobacterium and inhibit the growth of specific pathogens in vitro.̶- Proposed a new method of separating different species of Bifidobacterium, which used additional evolution adaptability of antibiotics, which successfully distinguished other species of Bifidobacterium in the infant gut model significantly saving experiment time for two weeks.- Analyzed and virtualized microbiota data from various meaningful perspectives using analytical tools like excel, GraphPad prism.- Cooperated efficiently with scientists from different countries and departments to generate new ideas and learn various experimental approaches. Show less

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  Pfizer

  Nov 2018 - Apr 2020

  Senior Regulatory Affairs Specialist

  - Created Regulatory Agency Electronic Submission Packages (Dossier) using several document management systems, building, publishing, validation, and archiving tools. - Responsible for EU and US markets. Operate as Subject Matter Expert (SME) in dossier types and act as a coordinator between the EU and India to facilitate the successful applications of several drugs. - Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission. - Played a key role in the industry-first project 'Volume 3 Advance Submission' and successfully assisted the product's global launch. - Hosted global awareness sessions successfully to announce the project Go-live, with more than 400 international colleagues attending. Show less

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  WuXi Clinical

  Apr 2020 - Oct 2020

  Regulatory Affairs Specialist

  - Participated in and completed three registration application projects, including clinical trial application and marketing application of China chemical drugs and biological products, FDA IND submission, anti-tumor new drugs, and anti-inflammatory drugs. - Understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. - Help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies - Organized and led the department's study of eCTD (electronic Common Technical Document). Established the template and working rules of the department. Show less

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  ETH Zürich

  Oct 2020 - Jun 2022

  PHD Candidate

  - Investigating the effect of different dietary novel proteins on human gut microbiota by in- vitro digestion of dietary proteins mimicking upper human digestion. - Literature review, protocol establishment, experiment design and performing, data analysis, and report presentation. Be familiar with different testing methods and analytical tools related to fermentation and gut microbiology. Gained knowledge and skills in bioinformatics, statistics, and project management - Use different molecular methods, chemical assays (qPCR, ultrafiltration, SDS-PAGE, enzyme assay) and different chromatography (HPLC, UPLC, GC) to quantify bacteria, protein and microbiome metabolites. - Supervisor of a bachelor's and a master's thesis. Show less

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  MIRAI FOODS

  Jun 2022 - Oct 2022

  Associate Scientist

  - Lead the protocol establishment, experimental design, sample preparation, and data interpretation. - Ensure the quantity and quality of cultivated meat products' micro and macronutrients by establishing testing capability in-house and via external partners. - Support toxicological safety assessment of cultivated meat according to EFSA, FDA, and SFA guidelines in line with MIRAI FOODS' go-to-market target. - Detail post-production processing steps to optimize nutrition, flavor, and texture and ensure product safety. - Engage in scientific and technical discussions to troubleshoot and improve existing SOPs. - Collaborate with the tissue engineering and media teams to investigate strategies to achieve the best meat quality. - Leverage process-product relationships affecting final attributes, and support the identification of ways to improve the nutrition and safety of cultivated meat products. Show less

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  CSL Behring

  Dec 2022 - Aug 2024

  Regional Regulatory Lead

  - Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU)). - Monitor local regulatory activities to ensure business objectives and timely implementation.- Be responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders. - Interact with Global Labelling relating to the labeling activities in the Region. - Support for the overall coordination and dispatch of responses to Health Authority questions, which include:Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders.Supporting internal stakeholders for the strategy, planning, and preparation of responses for complex scientific questions requiring product expertise. - Support Quality Management System strategy and Veeva-related document transformation process.- Responsible for GRA Policy/SOP/WI creation, review, approval, and ensuring consistency.- Regular review of global procedural documents status and analysis of status reports.- Ensure compliance of GRA local procedures with GRA global procedural documents.- Draft work-related procedures, e.g., onboarding process. Show less

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  Ziemer Ophthalmic Systems

  Apr 2024 - now

  Regulatory Affairs Manager

  - Successfully navigating complex regulations to ensure timely approval and market entry of the product in China.- Collaborating with clinical, technical, and R&D teams to resolve clinical and technical issues, strengthening the submission package.- Influencing stakeholders through effective technical exchanges with regulatory authorities, ensuring clear communication and securing approval.- Managing the entire regulatory process, ensuring alignment with timelines and strategic business objectives. Show less