Senior Research Associate

• Prepare submission check-list based on regulatory & product specific requirements
• Dossier 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 applicable
• Checking for the current version of documents for submitting it to Row market as per requirement
• Preparation 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

B.Pharmacy/M.pharmacy with experience of 4 to 8 years in Formulation Regulatory Affairs.