Customer Service Project

Yanan Li

*** ******** ****** ** ******, CA ***** C: 857-***-**** E: aczkso@r.postjobfree.com

EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices May 2015 GPA 3.72

Wuhan Bioengineering Institute Wuhan, China

Bachelor of Science in Biotechnology July 2011

GPA: 3.5

Honors: First prize scholarship in 2007-2008 academic year WORKING EXPERIENCE

America Youcare Pharma Inc. Corona, CA

Regulatory Affairs Associate Dec 2015- Present

Require DUNs and FEI number from FDA

Research on generic drug products and collect registration information

Research all legal standards for FDA and other agencies’ licensing of pharmaceutical manufacturing facilities, as well as known GMP for activities in the areas of manufacture, testing, development protocols and related matters

Maintain complete archive of regulatory records, including archive of formal submissions and FDA correspondence

Inspect all processes to identify potential issues of purity, precision, sanitation, etc., and bring any identified deficiencies and areas of concern to the attention of facility managers immediately. Suggest steps for remediation and improvement

Coordinate with Contract Research Organization for conducting pilot Bioequivalent study and pivotal BE study

Coordinate internally and assist Quality Control and Quality Assurance Department to update testing schedule for each active projects

Provide support to QC laboratory as needed, as on writing test method and test report

Review and collate development report about drug product formulation and required documents

Review and provide comments on draft batch record and execute batch record

Review product stability protocol and draft stability summary

Perform stability chamber monitoring and documentation, and pull out stability sample as scheduled per protocol

Maintain and manage accurate inventory related to raw materials and packaging components

Perform monthly physical counts and track the movement of finished products – released and quarantine products

Maintain and evaluate inventory logbooks by archiving the materials transfer form and related documentation

Provide assistance on Project Management, and monitor process of multiple projects to ensure the successful completion of the project

Prepare training materials for Project teams to provide regulatory guidance and foster best practices in all manufacturing, testing and precursor activities

Ensure that all project personnel receive an appropriate orientation to the organization and the project

Develop forms and records to document project activities, and set up files or systems to ensure that all project information is appropriately documented and secured

Assist New Business Development Manager to perform research on various companies for collaborations and CMO and joint venture projects

Westnet Inc. Canton, MA

Sales Assistant Aug 2015 – Nov 2015

Organized the sample room of medical devices and surgical equipment

Prepared documents and samples for show events in San Diego, Maine and Longwood medical area

Utilized a variety of resources and work collaboratively with Westnet’s customer service and inventory management staff to service, sell, and maintain customer accounts.

Created and managed customer accounts by using Salesforce RESEARCH EXPERIENCE

Northeastern University Boston, MA

Sept 2013 – May 2015

Researched and presented several clinical trial cases, such as a Bayesian adaptive dose-response trial and personalized medicines in clinical trials

Practiced on writing the Investigational new drug application (IND), New drug application (NDA) and Orphan drug annual report, Material safety data sheet

Analyzed the Warning Letter

Wuhan Bioengineering Institute Wuhan, China

Independent Researcher Jan 2011 – May 2011

Researched the extraction technique of lectin from black soybeans; investigated the physical and chemical factors affecting the Agglutination activity of black soybeans by utilizing ammonium sulfate precipitation, dialysis, and protein extraction

Conducted research on Agglutination activity of different beans on a team of four by filtrating and treating samples under different temperatures, pH values, alkali metal ions, and sugar inhibition, and compared the results with control groups

Coordinated daily schedule of using laboratory with cross-functional departments Wuhan Bioengineering Institute Wuhan, China

Laboratory Assistant Sept 2010 – Jan 2011

Practiced on Gel electrophoresis and PAGE to separate DNA and potent fragment

Analyzed agarose gel electrophoresis result and estimated the quality of extractive DNA and plasmid First Teaching Hospital, Tianjin University of Traditional Chinese Medicine Tianjin, China Laboratory Assistant July 2008 - Sept 2008

Assisted Professor Bangqi Wu with assessment of the spatial memory of Alzheimer’s mice

Researched acupuncture treatment and drug treatment for laboratory mouse model of rapid aging

Conducted toxicity and maximum tolerated dose studies in mice

Analyzed research data and final report to evaluate the effectiveness of the drug involved VOLUNTEER EXPERIENCE

Rosie’s Place Boston, MA

Team Leader Sept 2013 – Nov 2013

Recorded details of attendance and working hours of each team member by utilizing Excel spreadsheets; presented data to the Center of Community Service every week.

Familiarized with numerous departments

Prepared and served meals for an average of 220 poor and homeless women each day Ethos Organization Boston, MA

Volunteer May 2014

Assisted Ethos with Annual Senior Prom featuring lunch, dancing, and door prizes SKILLS

Languages:

Native speaker in Mandarin, fluent in English

Computer:

Proficient in MS Word, Excel, Microsoft Project and PowerPoint, and comfortable working with document management and other electronic submission systems Lab Techniques: Pipetting, centrifuging, aseptic technique, media preparation, plant tissue culture

Ability to perform basic molecular biology techniques such as plasmid construction PCR

Ability to investigate drug metabolism, the effect of drugs on humans, experimental design and statistics analysis

Regulatory Affairs Professional Abilities:

Knowledge of regulatory submission, compilation and approval processes, standards and systems

Knowledge of GLP, GMP,SOPs/ guidance, Change Control, Deviation report and OOS, ANDA application form (Form-356h), GDUFA fee (Form 3397), ANDA submission package and checklist, eCTD, IND Annual Report, IND-Information Amendment, Orphan Drug Annual Report, FDA 1571 Form, and Warning Letter Analysis

Others:

Ability to multi-task; excellent planning and organizational skills with attention to detail and accuracy

Eager to learn relevant scientific knowledge and new regulatory requirements

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