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Sukonya Bhattacharjee

GxP Quality & Regulatory Affairs Specialist | USFDA & EMA Compliance | Biologics | CAPA, ICH Q2(R2) | Cross-functional PMO

Pune/Pimpri-Chinchwad Area

2+ years of work experience

Enzene Biosciences Ltd
Jul 202511 mosPresent

Pune, Maharashtra, India

Enzene Biosciences Ltd
Jan 20257 mosJul 2025

On-site

Project Management Team
Enzene Biosciences Ltd
Nov 20243 mosJan 2025

On-site

Method Validation

Education

KIIT School of Biotechnology

B. Tech and M. Tech dual degree, Biotechnology

KIIT School of Biotechnology

20195 yrs2024
Nava Nalanda

12th Boards

Nava Nalanda

20172 yrs2019

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Headline

GxP Quality & Regulatory Affairs Specialist | USFDA & EMA Compliance | Biologics | CAPA, ICH Q2(R2) | Cross-functional PMO

About

Regulatory Affairs & GxP Specialist | Biologics | USFDA/EMA Supporting compliance-ready biologics through HPLC analytics, method validation & protein characterization. Contributed to EMA-aligned biosimilarity reports & regulatory submissions | Skilled in CAPA, ALCOA+ & QMS. Bridging R&D, Quality & Regulatory to drive submission-ready outcomes.

Location

Pune/Pimpri-Chinchwad Area

Work experience

Research Associate at Enzene Biosciences Ltd, Jul 2025 - Present · 11 mos, Pune, Maharashtra, India

Trainee- Research Associate at Enzene Biosciences Ltd, Jan 2025 - Jul 2025 · 7 mos, On-site, Project Management Team

Trainee at Enzene Biosciences Ltd, Nov 2024 - Jan 2025 · 3 mos, On-site, Method Validation

Education

B. Tech and M. Tech dual degree, Biotechnology, KIIT School of Biotechnology

12th Boards, Nava Nalanda

Sukonya Bhattacharjee - Research Associate in Pune/Pimpri-Chinchwad Area | Tal