Regulatory Compliance

4.00 to 5.00 Years Ahmedabad 27 Feb, 2024

Job Location	Ahmedabad
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	Not Mentioned
EmploymentType	Full-time

Job Description

Job Profile : Responsible for maintenance of Regulatory database in software for Global markets for all types of regulatory activities including submissions, post-approval, renewals. Read and understand the data from different source documents and maintain the same into RIMS software correctly. Quality control checking of data entry done by the team. Ability to lead team of three to four persons and need to provide training to the team for RIMS entry Good inter & Intra department communication/co-ordination skill. Preparation URS, SOP/Policy documents, functional testing of software, software validation, monitoring of day-to-day activity as per project plan, ensure regulatory compliance, review of project documentation, archiving of database, etc. knowledge in handling and management of eCTD softwareQualification : B. Pharm / M.Pharm/ Science Graduate / M.ScExperience : 4 5 years experience with Regulatory Affairs including eCTD, RIMS database maintenance.,

Keyskills :
Data entryQuality controlTeam leadershipTrainingCommunicationURSFunctional testingSoftware validationRegulatory complianceRegulatory database maintenanceSOPPolicy documentsProject documentation reviewDatabase archiving

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Regulatory Compliance

Job Description

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