I am a passionate and goal-oriented seasoned drug development executive with over 14 years of extensive global clinical operations and clinical sciences experience in oncology, neurology and metabolic orphan diseases at mid-size and start-up biotechnology companies; I have actively contributed to the registration of 3 medicinal products and led two investigational products from idea to phase II/III, overseeing all the clinical and regulatory operational activities. I have an in-depth knowledge of FDA/EMA regulations for GCP鈥檚, GLP鈥檚 and GMP鈥檚 and experienced in establishing and developing clinical operations, regulatory affairs and quality assurance systems. I have strong management and l...
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