Open to opportunities

Bharathi Kodali

@bharathikodali

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Experienced Regulatory Affairs professional with a focus on compliance excellence.

Germany

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What I'm looking for

I am seeking a role that values innovation and compliance, offering opportunities for leadership and strategic impact.

I bring over 16 years of global experience in Regulatory Affairs, Quality Assurance, and Quality Management Systems. My journey has equipped me with a unique perspective on how regulators think and what signals they trust. This insight allows me to partner effectively with sites to build audit-proof systems that not only pass inspections but also earn trust.

Throughout my career, I have held leadership roles at renowned companies such as Sandoz, Novartis, and Aurobindo, where I successfully delivered over 200 regulatory approvals and drove 28 global product launches. My commitment to innovation is evident through my application of Lean Six Sigma methodologies and AI tools, which have significantly improved timelines and quality outcomes. I thrive at the intersection of science, compliance, and innovation, ensuring that regulatory systems are not just inspection-ready but also future-ready.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Compliance Manager

Current

Sandoz

Oct 2023 - Present (1 year 9 months)

Architected global regulatory strategies including nitrosamines and CGT pathways. Introduced compliance checkpoints to mitigate risk early.

Regulatory Strategy Nitrosamines CGT Pathways Risk Mitigation Biosimilar Programs Submission Planning

Global Regulatory Affairs Manager

Novartis Health Care

Dec 2019 - Oct 2023 (3 years 10 months)

Orchestrated global submissions with 95% first-pass success. Reduced authority response cycles by 30%.

Regulatory Affairs Change Control

Scientist IV - Regulatory Affairs

Aurobindo Pharma Ltd.

Aug 2012 - Dec 2019 (7 years 4 months)

Delivered 40+ First-to-File ANDAs with Day 0 approvals. Led BE/BA clinical data integration into submissions.

First To File ANDAs Day 0 Approvals BE BA Clinical Data Integration Regulatory Affairs Extedo

Assistant Manager – DQA & RA

Zenara Pharma Pvt. Ltd.

Jul 2008 - Jun 2012 (3 years 11 months)

Converted R&D data into global submissions. Handled audits and deviation investigations with progressive resolution.

Audit Quality Assurance Regulatory Affairs Trackwise MasterControl

Education

Degrees, certifications, and relevant coursework

Annamalai University

Master of Pharmacy, Pharmaceutical Chemistry

Grade: University Gold Medalist

Activities and societies: University Gold Medalist

Awarded University Gold Medalist for outstanding academic performance in Pharmaceutical Chemistry. Focused on advanced topics in pharmaceutical sciences and research methodologies.

Sri Padmavathi Mahila Visvavidyalayam

Bachelor of Pharmacy, Pharmacy

Grade: First Division

Achieved First Division in comprehensive studies of pharmacy, covering foundational and advanced pharmaceutical concepts. Developed a strong understanding of drug formulation, pharmacology, and pharmaceutical analysis.