Senior Research Associate

19 hours ago

Prashanti Nagar IE Kukatpally Hyderabad Telangana, India Aveva Drug Delivery Systems Full time ₹ 6,00,000 - ₹ 12,00,000 per year
Job Details Prashanti Nagar IE Kukatpally Hyderabad, Telangana Day Senior Research Associate-RA
  • 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
M.Pharmacy

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

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