Job Responsibilities:
1. Biosimilar Regulated market submissions - US / EU regulatory submission.
2. Biosimilar Dossier Authoring (Drug substance and Drug product), MOH query response and Hands on experience in eCTD submissions
2. Biosimilar Product Development Strategy for CMC and Clinical development
3. Review of Quality documents including coordination with Cross functional teams ( R&D;, QC/QA and Manufacturing)
4. Biosimilar Product Life Cycle Management
5. RA support for Plant related QMS activities
📌 Manager RA(CMC) (Govandi East)
🏢 USV
📍 Govandi East
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