At Johnson & Johnson Innovative Medicine, I prepare and review SmPC, PIL, and label documentation for EMEA regulatory submissions, renewals, variations, and line extensions.
I support local partners and third-party translation vendors while ensuring labeling materials are accurate, clear, timely, and aligned with internal standards, global requirements, and applicable regulations. I also contribute to eLabeling, translation-support, XML/PDF comparison, and internal regulatory communication platform projects.
As part of the Regulatory Management Center, I mentored a new hire through structured shadowing and hands-on training in labeling workflows, quality standards, and documentation requirements.
Previously, as a licensed pharmacist at Eurofarm, I advised patients on medication use, side effects, and drug interactions, and dispensed prescriptions with careful dosage and compliance checks.
