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Research Scientist

4 months ago

Pune, India Lupin Full time

**Date**:Oct 30, 2023

**Location**: Pune Biotech, MH, IN

**Company**:Lupin

A) Job description:

- 1) Relevant experience in regulatory document preparation, dossier compilation, regulatory query response preparation.
2) A good understanding on the regulatory requirements for biosimilars submissions.
3) Basic knowledge on statistical analysis mainly related to stability data analysis and bio similarity assessment.
4) Experience in scientific writing (Analytical similarity assessment protocol/report, JOS, comparability protocol/report, risk assessment reports etc.) and prior experience in CMC

B) Relevant work experience - More than 5 years.

C) Education Qualification - PhD/M. Tech or MSc Biotechnology/Biochemistry.