Kalpana Vanam is the Senior Vice President, Regulatory Affairs, US at Lupin, where she leads the regulatory function for the U.S. organization and provides strategic regulatory leadership across the company’s Generics, Biosimilars, and 505(b)(2) portfolio.
In this role, Kalpana plays a pivotal role in advancing organizational objectives by providing strategic guidance on regulatory requirements, development pathways, and submission strategies throughout the product lifecycle. She collaborates closely with cross-functional stakeholders to ensure regulatory compliance while driving efficient development and approval pathways for complex products.
A recognized leader in regulatory strategy with more than 30 years of experience, Kalpana has been instrumental in securing approvals for complex and high-value products, including First Generics and Biosimilars. Her expertise in navigating regulatory challenges, identifying innovative solutions, and developing effective risk-mitigation strategies and continuous engagement with Regulatory authorities has contributed significantly to business growth and portfolio expansion. Through her leadership, she continues to support Lupin’s commitment to delivering high-quality and affordable healthcare solutions to patients.
Kalpana holds M.S in Microbiology and MBA in Healthcare Management. Prior to Lupin, she held senior level positions in Taro, Pfizer, Sandoz and Glenmark.
