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A pharmacologist with expertise in Regulatory Affairs, Quality Assurance, Intellectual Property Management and Regulatory Publishing.I have 6 years Experience in Regulatory Affairs and Regulatory Operations and have worked with many reputed MNCs in my previous assignments with onsite opportunity to visit Europe.
Working as Regulatory Affairs Specialist with a reputed Pharmaceutical Distributor/ Local Agent and submitting Drug and Medical device applications for marketing approval from Manufacturing Partners as mentioned below:
• Responsible for coordinating, reviewing and submitting Regulatory Applications to Saudi Food & Drug Authority and Gulf Health Council.
• Pharmaceutical Company registration with SFDA and GHC.
• Response to HA Inquiries in a time bound manner and ensure product lifecycle maintenance.
• Site qualification submission of Medical Device manufacturers with GHC.
• Medical Device manufacturer registrations through MDEL post legalized AR-Mandate.
• Medical Device Application submission through MDMA.
• Low risk Med Device registration through MDNR.
• Obtaining Import Permits for IVDs, Chemicals and Demonstration equipment through MDIL.
• Active communication with SFDA, GHC and Manufacturers to achieve regulatory milestones.
Deputed to work at AstraZeneca India Private limited for a global branded generics project.
