12 Aug
|
USV
|
Maharashtra
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
- Review of Quality documents including coordination with Cross functional teams ( R&D;, QC/QA and Manufacturing)
4.
Biosimilar Product Life Cycle
Management
- RA support for Plant related QMS activities
📌 Manager RA(CMC) (Maharashtra)
🏢 USV
📍 Maharashtra