Team Member

2 hours ago

Mumbai Maharashtra, India Cipla Full time

DivisionIPDDepartmentIPDEmployment TypePermanentJob PurposeSubmit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes maintenance and updation of documents during the products life-cycleAccountabilitiesI Achieve timely submission of dossier DMF and deficiency responses to regulatory authority by reviewing collating and compiling documents in order to ensure approvals for launch in stipulated time II Submit post approval variations for changes that improves productivity cost-effectiveness quality of the product by reviewing collating compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization Renewals Sunset clause to ensure continuous validity of marketing authorisations III Maintain and update product dossier as required to meet changes in Ciplas internal systems changes in regulatory guidelines and to meet the need of regulatory requirements IV Update the database PRC SAP-RA table associated with product dossier approvals by including registration details in database V Provide Regulatory support throughout the life cycle of the product for smooth functioning VI Provide the informatuitability and availability of dossier for out-licensing and in-licensing VII Check with regulatory authorities EU NZ TGA for submission activity and approval status for submission doneEducation QualificationB Pharmacy M Pharm Bsc or MScRelevant Work ExperienceMinimum 5 years xc3 xa2 xc2 x80 xc2 x99 experience in regulatory activity in pharma industry preferably worked for same region authorityCompetencies SkillsCollaborate to SucceedInnovate to ExcelPerform with AccountabilityLead with EmpathyAct with AgilityStrong Domain KnowledgePeople ManagementJob LocationMumbaiShift Hours

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