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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
You will be based at Coorporate Office at Mumbai . You will br responsible for : 1.Preparation and Execution of Drug Master files of API in CTD and ECTD format, independently in coordination with plant people. 2. Checking and reviewing of documents required for DMF filing received from plant for its thoroughness and getting corrections done from plant. 3.Handling to DMF deficiencies Preparation of action plan and deficiency responses. 4.Timely Response of DMF/CEP deficiencies. 5.Annual updates of DMF and renewal applications for CEP. 6. Review of quality and analytical data as per regulatory requirement of various market. Required Candidate profile1. You should be b.Sc/M.Sc -Chemistry / B.Phar,ma/ M.Pharma .2. You should be 2-4 years of experience in Regulatory affairs . 3. You should be good in Analyst, R&D chemist, Analytical method development, quality compliance analyst, production chemist, QC chemist. 4. You should be good inPreparation and Execution of Drug Master files of API in CTD and ECTD format,,
Keyskills :
analytical method developmentregulatory affairs method developmentquality compliance api dmfctd