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Job Location | Mumbai City |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD |
EmploymentType | Full-time |
Roles and ResponsibilitiesYou will be based at a Corporate office at Mumbai.You will be responsible for,1. Candidate will be responsible for Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. 2. Candidate will be responsible for Prepare responses to the legal & technical queries raised by the Regulatory authorities 3. Candidate will be responsible Co-ordinate with QC and R&D departments for technical documents required to be incorporated in the registration dossiers. 4. Candidate will be responsible for Ensure timely renewal of drug and food licenses maintained by head office and also branch offices based at various states in the country.Desired Candidate Profile1.Candidate should be M. Pharm and 5+ years of experience in Regulatory Affairs in Domestic / Row market in registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. 2. Candidate should have experience in Formulate and implement statutory requirements pertaining to the artworks of the products.3. Candidate should have experience in Review the artwork of all packaging material and Prepare package insert.,
Keyskills :
artworkstatutoryabbreviated new drug applicationdraftingdcgielectronic common technical documentbranch officesregulatory affairsregulatoryregistrationregulatory submissionsgeneric programmingpackagingcolordocumentationclarifycosmetics