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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Rs 4.0 - 8 Lakh/Yr |
| Industry | Retail |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Opening in Pharma Formulation MNC Company for Senior Regulatory Affairs in Mumbai(Andheri)Position - Sr. Officer / Executive / Sr. Executive / Assistant ManagerDepartment: Regulatory Affairs EU Market Location - Mumbai (Andheri) Qualification-B Pharma or M PharmaExperience- 4-9 years work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Roles and ResponsibilitiesTo be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirement Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage Should have Practical Knowledge for Europe VariationsShould have practical experience for CMC SectionShould have experience for Life cycle management and license MaintenanceInitial Filling from Module1 to Module5Should have good knowledge for recent guidelines ,websites and trends of Europe MarketShould have practical knowledge for API and Formulations in Pharmaceutical Company-Kindly send me your updated CV on ********@sharppoint.in with below mention details
Keyskills :
apiichpreparationelectronic common technical documentlife cycleregulatory affairsanalytical developmentfillingctcpharmamanagementctdregistrationanalyticalformulationproduct developmentregulatorycmc