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DRA Jobs at Gracure Pharmaceutical


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DRA Jobs at Gracure Pharmaceutical

Gracure Pharmaceutical Ltd. is a Delhi based pharmaceutical company, established in 1992 by Mr. A.S Bhargava with the vision of making world class affordable medicines. Gracure is a research driven forward looking pharmaceutical company with expertise in development of various finished dosage.

Department : DRA - Delhi Location

Experience : 2-7 Years

Job Description :
• To compile the dossier in CTD and ACTD format as per the regulatory requirements of regulated markets (Europe/UK/Canada/Australia) or Semi-Regulated market (Malaysia, Singapore, Tanzania, Zimbabwe, South Africa, Saudi Arabia etc.)
• To arrange the documents from different stakeholder and review the documents as per RA adequacy to provide the quality dossier for submission to partner as per the predefined timelines.
• Should have the knowledge of regulatory guidelines of the main regulated body such as ICH, WHO, EMA etc.  
• To compile the response of a query received from Partner/Agency.
• To ensure the life cycle management of products to smoothen the market supply of products.
• Review the drug master file of active ingredients as per regulated and semi-regulated market requirements.

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Last Date : 30th November, 2022

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