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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Bio Tech / R&D / Scientist |
| EmploymentType | Full-time |
Dear Candidate,Were Opening forExecutive Regulatory AffairsRoles & Responsibilities :-Dossier preparation for eCTD market UK , EU , Australia & Newzealand & VARIATION filing in EU/Australia marketNew project Execution , Should review MFR,PDR,BMR,PVR,SPECS MOA ,STABILITY , ERA,NDMA. Should have knowledge of product lifecycle managementRFI Response , customer queriesShould be well versed with EMEA, TGA and ICH Guidelines. Should visit site for required documents for dossier submission and RFI response as and when requiredShould be strong in communication and correspondence.Desired Skills:Quality , RND (Product development), Dossier Preparation eCTD format. Very well versed with EMEA GuidelinesEfficient Problem solving , Effective communication, creative thinking , Should be Bold /challenge seeker, positive attitudeRegards,Team HR
Keyskills :
product developmentregulatory affairsdossier preparationemea