Regulatory Affairs Professional with extensive scientific background and regulatory affairs experience in preparing and submitting quality dossiers to governmental agencies (FDA, CVM, EPA, etc) for new drug approvals. Strong people skills and proven track record in facilitating regulatory strategy, meeting project registration deadlines and positive interactions with regulatory agencies. Serve as a regulatory representative on cross-functional technical teams and provide expert advice for product registration teams.Communicating with governmental agencies for drug registrations, product labeling, drug shipment/import/export notifications, master files, data package submissions, regulatory correspondence, and protocol reviews. CMC responsibilities include developing filing strategy with all internal relevant groups, establishing schedule to monitor the progress, requesting documents from outside suppliers/contractors, reviewing manufacturing documents (specifications, batch records, reports, sterilization procedure, etc), monitoring the stability program, communicating/meeting with regulatory agency on proposed submission data package, compiling the CMC dossiers for synthetic or/and DNA recombinant drugs, tracking agency’s review process with timely responses to agency’s questions, etc. Labeling responsibilities include drafting text for insert and packaging contents, evaluating efficacy/safety indications, summarizing precautionary statements, outlining drug application procedures, negotiating label language with agencies, amending/updating approved labeling, monitoring competitors’ labeling on the market, keeping marketing/sale colleagues up to date with regulatory labeling requirements, etc. In addition, serving as company liaison to interact with various regulatory agencies, developing product registration strategies, and continuously updating the internal staff with the awareness of regulatory requirements.Specialties: academic, administration, research, scientific, teaching,