Senior Research Associate

1 week ago

hyderabad, India Aveva Drug Delivery Systems Full time

Job Details Prashanti Nagar IE Kukatpally Hyderabad, Telangana Day Senior Research Associate-RAPrepare submission check-list based on regulatory & product specific requirementsDossier compilation and review of ANDA's for different dosage forms.Review of all technical documents which are required for ANDA compilation (Specifications, STP, COA's, protocols, BMR's, BPR's, Bio related documents etc....)Review of documents (Master BMR's, Master BPR's, specifications, protocols, EIR report, IIG etc...) received from other cross functional teams for the products under development.Preparation and review of controlled correspondences for different dosage forms as per the R&D request.Compilation of sections required for query responses received from Agency.Communicating with the cross functional teams and CMO's for requesting the documents required for ANDA compilation.Compilation of post approval submissions (CBE-30, PAS) if applicableChecking for the current version of documents for submitting it to Row market as per requirementPreparation of checklists (to review the BMR, BPR, ANDA document request, ANDA checklist for internal references).Checking for USFDA current updates and new Guidance's published in website.Training to fresher in the department with all Regulatory Affairs aspects.Reviews document change controls.Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation.Following with USFDA and EMA sites for current updates.Any other related duties as assigned by Team Leader M.Pharmacy B.Pharmacy/M.pharmacy with experience of 4 to 8 years in Formulation Regulatory Affairs.

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