Description
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements through all phases of drug development, post-approval, and life-cycle of the product. Possess the skill and ability to effectively audit and review pre-clinical and clinical documents. Knowledgeable in Clinical Trial Management and Pharmacovigilance to develop project specifics related to training different teams, achieve deadlines and collaborate with colleagues on a global level.
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