Handled about 60 times regulatory authorities & customers GMP inspections/audits from 18 over countries, and experienced with audit preparation, interaction with inspector as well as audit report responses. (Several fruitful US FDA inspection results with no 483 observation; Japan PMDA inspection with minor observations; Taiwan FDA inspections for facilities GMP approvals) Leaded & completed about 70 cases of DMF/ASMF submissions and regulatory deficiency responses in 16 countries with outcomes of successful regulatory approvals.Possess 8+ years' experience in Pharmaceutical Industry & 4+ years of Management experience. Strong expertise in QA & RA professional with a Doctor of Philosophy (Ph.D.) & Postdoctorate focused in Biotechnology, Polymer Chemistry & Chemical Engineering.Skilled in developing systematic management and innovative in designing formula, report & templates based on current regulatory requests, e.g. QTPP, CQA & CPP (using QbD concept), (Q)SAR Modeling for Genotoxicity, HBEL concept in determining cleaning limits, ICH Q9 risk assessment design for re-validation & elemental impurities based on ICH Q3D, OOT formula for product release and stability, etc.Able to Handle Stressful Situation and Adapt to Challenging Environment, with Good Organizational, Communication and Interpersonal Skills. Efficient Problem Solver, Logical, Analytical, Responsible, Creative & Innovative, Proactive, Effective, Independent, Critical and Global Thinker.Competent in using EXTEDO eCTD Manager, Sigma Plot, Derek & Sarah Q(SAR) GTI prediction software, ChemDraw, Adobe Professional, Excel, Microsoft Ofice, PowerPoint, Photo Impact, ImagePro, ImageJ, Origin, IsisDraw. Master in SPC, 6-sigma, instrument analysis (i.e. LC/GC, NMR, FTIR, DSC, TGA, SEM, DMA, Ellipsometry), Microbiological analysis, eCTD Drug Master File Filing & Update, Regulatory Observations & Authority Response, GMP Inspection and Customer Audit, Product Quality Review, Establishment of SOPs, Site Master File & Validation Master Plan, Deviation Investigation & CAPA, Research & Analytical Skills, Biomaterials & Biopolymers, ATRP Synthesis, Electrospinning, Fed-Batch Fermentation/Bioreactor Set-up and Chiral Technology.