Dear candidate,
We have a requirement from #Gracure Pharmaceutical Ltd at Delhi Location. Interview mode telephonic The Details are:
Department: DRA
Experience: 2-3 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 main regulated body such as ICH, WHO, EMA etc.
To compile the respond of query from received from Partner/Agency.
To ensure the life cycle management of product to smoothen the market supply of product.
Review the drug master file of active ingredients as per regulated and semi-regulated markets requirements.
If Interested, please share your resume on aakansha.agarwal@gracure.com Kindly share contacts of your friends/colleagues also, we will call them.
