Madhuresh Kumar Sethi Ph.D, IICA — CEO

I build pharmaceutical innovation that survives patents, regulators, and scale—transforming complex chemistry into protected market access across the US, EU, Japan, Australia, and emerging markets. I help boards convert scientific and regulatory risk into defensible, scalable enterprise value. I have advised CEOs on enterprise decisions and delivered patent-safe APIs and complex generics. Matrix, Mylan & Viatris: I led chemical R&D, CMC, regulatory strategy, and IP defense across APIs, complex injectables, and nanomedicine platforms. R&D Innovation with Business Impact: At enterprise scale, I translated scientific strategy into defensible portfolios, regulatory approvals, and sustained revenue growth across global markets. Secured 100+ patents (including 10+ green chemistry), 30+ US/EU regulatory submissions, and drove five first-to-market launches unlocking USD 500M+ in annual protected revenue. Global Regulatory Leadership: Obtained USFDA, EU, and WHO approvals, including USFDA Glucagon (2024) and EU-approved iron carbohydrate nanomedicines, improving product safety, stability, and manufacturability. Scalable Manufacturing & Operations: Led green chemistry and advanced CMC to deliver compliant, cost-effective scale-up, achieving 25% waste reduction and 20% faster time-to-market. Policy & IP Leadership: Drove policy advocacy and due diligence for licensing, technology transfers, litigation, patent oppositions, and regulatory responses. IP Litigation & Market Exclusivity: Partnered with legal teams on Para IV execution and FTO, securing multimillion-dollar settlements. People Leadership: Built and mentored global teams of 100+ scientists achieving compliant R&D cultures. Recognition: Metrix Achievement Award winner; RSC book chapter author; global conference speaker; member of leading chemistry, IP, and board bodies; editorial board member; featured in major business media. Board-Ready Governance: Specialized in technical audit, risk management, and ESG frameworks for IP-intensive environments. I currently advise on AI-enabled R&D strategy, IP risk, regulatory readiness, and ESG/BRSR integration—helping boards balance innovation ambition with compliance, capital protection, and long-term value creation. I am seeking Board Advisory or CXO-level roles to drive policy advocacy, innovation, and global growth. Let’s connect: boardmks25@gmail.com | +91 8008001545

Stackforce AI infers this person is a Pharmaceutical R&D and IP Strategy Leader with extensive regulatory experience.

Location: New York City, New York, United States

Experience: 30 yrs 1 mo