Doris Lin Email & Phone Number

Taiwan

台南地區

1.Regulatory consultancy and training: provide guidance interpretation and submission strategies.2. CMC compiling for DS part of IND,NDA,ANDA.3. Project evaluation and proposal writing(budgets, resources, tasks and schedule project timeline.)4. Project tracking and problem solving./Application Field/Small molecules, Peptide and Oligonucleotide, Antibody-drug conjugate (ADC)

1.Health hazard assessment including toxicological data(e.g., acute toxicity, genotoxicity, carcinogenicity),WoE assessment for carcinogenicity.2.Collect and organize the chemical regulations and strategies from US EPA, FDA, OECD and IARC.3.Regulatory consultancy and training: SDS, GHS classification and Preparing of Chemical Safety Report (CSR)./Application Field/Regulations of New and Existing Chemical Substances

1. Prepare and establish ISO documents and SOP.2. Review analytical test reports, microbial test reports, process validation reports, and batch production records.3. Support vendor qualification and audit activities./Application Field/Sterile API and sterile lyophilized drug product

1. DMF preparation and global submission: TW, US, Japan, China, CEP for EU2. Dossier management and change control: Original submission, annual reports, amendments, post approval change/variation, response to deficiency letters.3. Technical consultancy:-Dealing with hundreds of commutations with authorities (Taiwan, FDA) and customers./Application Field/API for Generic drug : small molecules, peptides

1. Prepare risk management reports and software validation reports for medical devices including blood glucose meter, blood pressure meter and thermometer.2. Review and approve of ISO documents.3.Communicate with customers and authorities about the risk management issues for medical devices./Application Field/Regulations of Medical device

1. Gather the news and guidance's of Communicable Disease from the world for the prevention and control strategies.2. Arrange the meeting of Communicable Disease by contacting Doctors and Commanders.

Master'S Degree, Biochemistry And Molecular Cell Biology

“Topoisomerase I inhibiton mediates evodiamine cytotoxicity on cancer cells”.

Bachelor'S Degree, Life Science