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BSc in Biochemistry, MA in Organic Chemistry |
15 years of regulatory experience: Syntex, Alza, Wyeth-Ayerst, Salix, Sugen and numerous clients
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Regulatory Affairs certified (RAPS) |
knowledge of FDA, HPB, UK, EU and ICH regulations and guidelines
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FDA/HPFB/MCA experience
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extensive experience writing documents for regulatory submission |
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therapeutic area experience: antivirals, anti-infectives, dermatologicals, cardiovascular agents, non-steroidal anti-inflammatories, pulmonary drugs, drug/device combinations, gastrointestinal and endocrine products, controlled release delivery |
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Margie Nemcik-Cruz: mncruz@pacbell.net