Regulatory Affairs Labeling (Bengaluru)

Regulatory Affairs Labeling (Bengaluru)

14 Nov
|
Parexel
|
Bengaluru

14 Nov

Parexel

Bengaluru

Job highlights

- Experience with regulatory labelling, CP/NP/DCP/MRP submissions, and Veeva Vault

- Prepare and update labelling documents, coordinate artwork updates, handle HAQs, and communicate with stakeholders

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

📌 Regulatory Affairs Labeling (Bengaluru)
🏢 Parexel
📍 Bengaluru

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