Eight years of manufacturing operations, management and leadership experience in pharmaceutical Industry. Perfectly managing the internal and external audit preparation (UK MHRA and TGA). Successfully executed ANDA submission batches.
Basic knowledge in IND submission (project work), NDA and ANDA mechanics for US FDA; CMC; Drug product labeling, advertising and promotion; regulatory compliance and enforcement action and in global regulatory requirements for Europe Union (EU) and Canada.
Practical experience on
鈥淪ubmission of IND Application of Chlorvincanol to HA鈥� as a part of MS program.
鈥淣egotiation with HA for warning letter on a...
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