Post : Lead Associate - Regulatory Affairs
Job Description
• 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
Candidate Profile
Any Graduate / Post Graduate
Pharmacy / Science
Additional Information
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
