Executive
Job Description
Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market Preparation of query response of drug substance for various and less regulated markets and customers. Preparation of applicant part and closed part for various authorities for different customers. Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, Preparation and submission of CEP applications and responses to EDQM via CESP. Preparation of CEP LOA's & LOA's and declarations of various customers and authority. To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers
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Job Detail
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Job IdJD3898278
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDholka, Gujarat, India
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EducationNot mentioned
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ExperienceYear