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Arunima Pandey

Regulatory Affairs Executive I CMC I Biosimilars

Ahmedabad

3+ years of work experience

Intas Pharmaceuticals
Mar 20251 yr 2 mosPresent

Ahmedabad, Gujarat, India

• Managed regulatory submissions for biosimilar mAbs and CGT products across global (EMA MAA, IMPD), emerging, and domestic markets (Phase I CTA). • Authored and reviewed CMC modules (2.3, 3) and Administrative/Regional Information Module 1, evaluated Non-Clinical Overview module (2.4) and Clinical modules (2.5, 2.7) for regulatory readiness. • Handled Day 120 LoQ and Day 180 LoOI responses through CMC writing, cross-functional leadership, CHMP scientific advice assessment, and review of eAF, cover letters, and artworks. • Supported early-stage FDA BLA preparation through Agreed iPSP submission and preliminary checklist development. • Experienced in change control assessments, eCTD structure readiness for publishing and validation and risk registry preparation.
Biocon Biologics
Sep 20231 yr 6 mosFeb 2025

Responsible for Downstream purification process development for biosimilar insulin analogs including crystallization studies and in-process protein analysis using preparative chromatography and analytical HPLC. Implemented DOE studies for purification optimization and integrated experimental data with project objectives.
Biocon Biologics
Mar 20237 mosSep 2023

Hands-on experience in biosimilar mAb drug product formulation and development through pre-formulation studies, stability studies, and forced degradation studies across multiple stress conditions. Conducted analysis of in-process samples and finished products using SEC, cIEF, CE-SDS, and physico-chemical techniques.

Education

bangalore university

Master of Science, Biotechnology

bangalore university

20192 yrs2021

Bachelor of Science, Biotechnology, Genetics, Biochemistry

The Oxford College of Science, Bengaluru

20163 yrs2019

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Headline

Regulatory Affairs Executive I CMC I Biosimilars

About

Regulatory Affairs professional with expertise in global biosimilar submissions and early-stage advanced therapies (CGT), integrating prior hands-on scientific experience in downstream processing and formulation development with strategic regulatory capabilities for accelerated global approvals. Passionate about bridging laboratory insights with regulatory digital transformation to deliver robust dossiers advancing safe and effective medicines worldwide.

Location

Ahmedabad

Work experience

Regulatory Affairs Executive at Intas Pharmaceuticals, Mar 2025 - Present · 1 yr 2 mos, Ahmedabad, Gujarat, India, • Managed regulatory submissions for biosimilar mAbs and CGT products across global (EMA MAA, IMPD), emerging, and domestic markets (Phase I CTA). • Authored and reviewed CMC modules (2.3, 3) and Administrative/Regional Information Module 1, evaluated Non-Clinical Overview module (2.4) and Clinical modules (2.5, 2.7) for regulatory readiness. • Handled Day 120 LoQ and Day 180 LoOI responses through CMC writing, cross-functional leadership, CHMP scientific advice assessment, and review of eAF, cover letters, and artworks. • Supported early-stage FDA BLA preparation through Agreed iPSP submission and preliminary checklist development. • Experienced in change control assessments, eCTD structure readiness for publishing and validation and risk registry preparation.

Scientist at Biocon Biologics, Sep 2023 - Feb 2025 · 1 yr 6 mos, Responsible for Downstream purification process development for biosimilar insulin analogs including crystallization studies and in-process protein analysis using preparative chromatography and analytical HPLC. Implemented DOE studies for purification optimization and integrated experimental data with project objectives.

Intern at Biocon Biologics, Mar 2023 - Sep 2023 · 7 mos, Hands-on experience in biosimilar mAb drug product formulation and development through pre-formulation studies, stability studies, and forced degradation studies across multiple stress conditions. Conducted analysis of in-process samples and finished products using SEC, cIEF, CE-SDS, and physico-chemical techniques.

Education

Master of Science, Biotechnology, bangalore university

Bachelor of Science, Biotechnology, Genetics, Biochemistry, The Oxford College of Science, Bengaluru

Arunima Pandey - Regulatory Affairs Executive in Ahmedabad | Tal