Ann, YI-An Lu

Experience

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  TTY Biopharm Company Limited

  Jun 2012 - Sept 2012

  Sales Intern at TTY Oncology Business Unit (TOT)

  • Research and generate lists of potential customers in medical centers in Northern Taiwan, including Cathay General Hospital, MMH, and Shin Kong Wu Ho-Su Memorial Hospital.• Provide input on product (Lipo-Dox) presentations and sales literatures in internal meetings.

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  財團法人醫藥品查驗中心 (Center for Drug Evaluation, CDE)

  May 2014 - Feb 2015

  Regulatory Project Manager(IND/BSE)

  • Reviewed IND/BSE all disease product submissions. • Planned and coordinated multidisciplinary meeting activities supporting procedures preparing communications of scientific and administrative issues, and recommended regulatory actions to pharmaceutical companies.• Coordinated and documented internal TFDA/CDE meetings and meetings with regulatory actions.

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  Parexel

  Aug 2016 - Nov 2016

  Clinical Trial Associate I

  • Previously a CRA Intern, promoted to full-time role• Collected, reviewed, organized, and assembled regulatory start-up and amendment submissions for oncology drugs to the IRB of Veterans General Hospital.• Ensured the clinical sites prepared and had the approvals needed from IRB to start the clinical trials.• Assisted in negotiating contracts and budgets at the site level.

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  Delta Synthetic Co., Ltd.

  Jan 2019 - Jun 2021

  RA and QA Pharmacist-in-Charge

  • Passed 3 on-site cGMP inspections from US FDA, TFDA, Japan PMDA in 2019, and obtained inspection documents successfully afterwards (i.g., cGMP certification from TFDA, EIR with zero violation on FDA Form 483 of FDA inspection)• Prepared regulatory registration filings of all products to TFDA, including changing/extension of DMF, and application for import permit of raw materials • Oversaw authority/global pharmaceutical company inspections and prepared corresponding inspection reports in English.• Achieved a 90% reduction in audit issues in the position Show less

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  Wearifi, Inc.

  Jul 2021 - Jun 2022

  RA and QA Engineer

  • Reviewed, organized, and assembled initial regulatory filing of 510k submissions of wearable medical devices to FDA.• Searched health authority regulatory requirements for wearable devices for US customers.• Collected and analyzed clinically relevant data for Class II wearable medical devices.• Collaborated with and demonstrate how devices will be used on clinical subjects for collecting clinical trial data to the dermatologist and the clinical research coordinators.• Fabricated adhesives and outer layers for the encapsulation of skin hydration sensors and fabricated/calibrated after integration of electronic component of EPP companion diagnostic. Show less

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  PharmEng Technology

  Jul 2022 - now

  Senior Consultant & RA,QA,PV

  Regulatory authority: Taiwan FDA• Led BLA submission for a biologic product, securing approval in 7.5 months.• Submitted 4 PMF applications, with 3 approvals (1 ongoing):--Biologic drug substance manufacturing site (approval in 3.5 months).--Blood product drug product manufacturing site (renewal-ongoing).--Protein-based vaccine drug product manufacturing site (approval in 4.5 months).--Packaging facility (approval in 6 months).• Transformed EUA vaccine into a registered product and partnered with the Commercial Head and distributor to drive market entry, achieving approval within 2 months post-BLA.• Collaborated with a CRO ranked among the World's Most Admired Companies in the medical and pharmaceutical consulting field (2022-2023), conducting 2 GMP audits for Taiwan's largest CDMO, generating 4 evaluation reports within 3 days post-audit.• Served as the Responsible Person for Pharmacovigilance in Taiwan, managing a biological vaccine and a blood product to ensure full regulatory compliance and effective safety monitoring during both the launch and post-market phases.• Managed life cycle and technical amendments for a Class II SaMD:Listed the SaMD at 2 medical center hospitals, handling bidding, operations, and license renewal, and liaising between the medical device company and hospital users.Regulatory authority: Hong Kong Department of Health (HK DOH)• Oversaw the lifecycle management of psychiatric medications in Hong Kong, including 2 manufacturing site changes and 4 packaging updates successfully submitted to the HK DOH.• Supported tender acquisition with the Hospital Authority of Hong Kong, ensuring a stable market supply.Regulatory authority: Singapore Health Sciences Authority• Assisted in compiling the EUA vaccine to the Singapore Health Sciences Authority (HSA), achieving approval in just 7.5 months from submission to approval. Show less

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  Novavax

  Feb 2024 - now

  Senior Consultant - Global Regulatory Affairs Europe and ROW

  Supporting Novavax Europe and ROW teams in successfully entering the Taiwan market by achieving the following milestones:• Secured regulatory approval: Transformed the EUA vaccine into a fully registered product within 8 months, ensuring compliance with TFDA requirements.• Accelerated timelines: Reduced submission-to-approval time for critical regulatory processes by 30%, meeting urgent market demands.• Streamlined operations: Developed and executed a regulatory strategy that enabled the product’s launch in Taiwan, impacting 200,000 people.• Cross-functional collaboration: Partnered with global teams to navigate complex regulatory frameworks, ensuring compliance across 100% of submission dossiers. Show less