Ann, YI-An Lu

Ann, YI-An Lu has a diverse work experience in the pharmaceutical and medical device industry. Ann, YI-An has worked as a Senior Consultant & BD, QA/RA/PV at PharmEng Technology since 2022, where they are involved in NDA/NCE/NBE registration and discussion, life cycle management for medical devices, gap analysis of CMC documents and Investigational Brochure, regulatory analysis of ATMP and orphan drug products, EUA vaccine amendment/submission support, and Drug Master File (DMF) and MAH maintenance support.

Prior to this, Ann worked as a Regulatory and Quality Affairs Engineer at Wearifi, Inc. from 2021 to 2022. Their responsibilities included reviewing and organizing regulatory filings for 510k submissions, finding regulatory requirements for US customers, and collecting and analyzing clinically relevant data for wearable medical devices.

Before joining Wearifi, Inc., Ann worked as a Regulatory Affairs and Quality Compliance Pharmacist at Delta Synthetic Co., Ltd. from 2019 to 2021. During their time there, they successfully passed cGMP inspections from US FDA, TFDA, and Japan PMDA, prepared regulatory registration filings, and oversaw authority/global pharmaceutical company inspections.

Ann has also gained experience as a Cancer Researcher Assistant at Taiwan Association of Cancer Patients from 2017 to 2018, a DRX and De-Zhen Clinic Pharmacist at a Dermatology/Obstetrics and gynecology clinic from 2017 to 2018, a Clinical Trial Associate/CRA Intern at Parexel in 2016, a Professional Sales Representative at Merck from 2015 to 2016, a Regulatory Project Manager (IND/BSE) at 衛生福利部食品藥物管理署 from 2014 to 2015, and a Sales Intern at TTY Biopharm Company Limited in 2012.

Throughout their career, Ann has demonstrated strong expertise in regulatory affairs, quality compliance, clinical trials, sales, and project management.

Ann, YI-An Lu has a strong background in pharmaceutical science and biotechnology management. Ann, YI-An completed their Bachelor's Degree in Pharmacy at Taipei Medical University from 2008 to 2011. Following that, they pursued a Master's Degree in Pharmacy, Pharmaceutical Sciences, and Administration at the same university from 2011 to 2013.

In 2021, Ann joined the National Taiwan University to pursue another Master's Degree. This time, they enrolled in the Professional Master's Program of Biotechnology Management (PMBM), which they are expected to complete in 2023.

To complement their academic achievements, Ann has obtained additional certifications. In 2021, they completed the CERSI Immersion Course in Drug Discovery, Drug Development, and Regulation offered by the University of California, San Francisco. Ann, YI-An also holds a certificate of completion in Pharmaceuticals EU Regulations from the Regulatory Affairs Professionals Society (RAPS), which they obtained in May 2022. Additionally, Ann is a registered Taiwan Pharmacist, certified by the Ministry of Health and Welfare in Taiwan. Unfortunately, the specific month and year of obtaining this certification are not provided.