- Providing the support to regulatory affairs team at Pharmazone as Senior Executive.
- Timelines management and delivery of the project.
- Looking after Documentation of the regulatory affairs department.
- Technical review of documents of products received from client for registration purpose.
- Undergoing Gap analysis of documents/data required for dossier preparation.
- Drafting and review of dossier for drug substance, drug product and administrative sections
- To update regulatory guidelines knowledge database regularly.
- Work together with cross-functional teams to ensure regulatory requirements are met throughout the dossier submission and product lifecycle management
- Prepare & review the responses for deficiency letters received from health authorities during the evaluation of marketing authorization/drug registration procedures.
- Perform regulatory submission procedures for US (ANDA), Europe, and other ROW markets.