Regulatory Affairs Labeling

Regulatory Labelling

• Labelling M1 Support Preparation of PI, Cover letter, eAF, Literature reference
• Update impacted labelling text (SmPC, PIL, Labels)
• Artwork update coordination
• Handling HAQs related to labelling submission
• Understanding of CP/ NP / DCP / MRP submissions
• Review if HA SPC (MHRA or HPRA) vs effective GSK/ViiV SPC
• RLCR Preparation for approvals
• Updating all labelling related information applicable for UK or IE submission / approvals.
• Effective communication skills with stake holders
• Veeva vault experience