Intas Pharmaceuticals
Location
Ahmedabad | India
Job description
Job Profile :
Responsible for maintenance of Regulatory database in software for Global markets for all types of regulatory activities including submissions, post-approval, renewals. Read and understand the data from different source documents and maintain the same into RIMS software correctly. Quality control checking of data entry done by the team. Ability to lead team of three to four persons and need to provide training to the team for RIMS entry Good inter & Intra department communication/co-ordination skill. Preparation URS, SOP/Policy documents, functional testing of software, software validation, monitoring of day-to-day activity as per project plan, ensure regulatory compliance, review of project documentation, archiving of database, etc.. knowledge in handling and management of eCTD software Qualification : B. Pharm / M.Pharm/ Science Graduate / M.Sc Experience : 4 – 5 years experience with Regulatory Affairs including eCTD, RIMS database maintenance.Job tags
Salary
