AGM-GRA (Regulatory Affairs)
Kashiv Biosciences LLCAhmedabad, Gujarat, India
Posted September 26, 2025
Full Time
About the Company
Kashiv Biosciences LLC specializes in biosimilar manufacturing and process equipment support, offering HVAC and BMS maintenance, equipment validation, and intellectual property services for downstream cell culture processes. The company operates in a GMP-compliant environment, providing technical expertise in bioreactor, fermenter, and downstream process equipment maintenance and IP strategy development.
Job Description
This position involves leading/supporting the filing of Biosimilars, NCEs and ANDAs in emerging markets, including Japan, Canada, and ANZ. The role focuses on regulatory support, including query responses, audit support, and lifecycle management. Candidates should have a Masters degree in the relevant field.
Requirements
- 12-15 years of experience
- Exposure in Emerging markets, Regulated Markets, Regulatory guidance
- Dossier Preparation
- Biosimilars and NCEs
