Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Post : Lead Associate – Regulatory Affairs
• Work with the Graphic Arts Specialist to create artwork for printed packaging components.
• Proofread text for labeling of pharmaceutical products as required by FDA (21 CFR 201).
• Ensure that labeling artwork and proofs meet all medical, legal and regulatory requirements.
• Ensure the accuracy of commercial packaging components.
• Connect with labeling managers in India to ensure any new US regulations are incorporated.
• Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components.
• Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for FDA submission and production (including sup-port of product launch).
• Provide input for internal tracking database in order to control workflow and to ensure FDA submission and/or production deadlines are met.
• Be responsible for assigning a unique text number to the package inserts ensuring the use of an accurate version.
• Provide editorial support to DRA managers by reviewing package inserts (new and revised) to ensure SPL/PLR compliance.
• Configuring new sites and SharePoint for RA
• Monitoring bandwidth usage and in and out knowledge for handling SharePoint.
• Deleting old files to save space
• Running and maintaining backups within the RA
• Deploying custom features
Any Graduate / Post Graduate
Pharmacy / Science
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September, 2020