Manda Pasarkar, Director of Global Regulatory Affairs, CMC at Sanofi, is a regulatory CMC expert with over 20 years of experience in the pharmaceutical industry in the USA. Specializing in synthetic and biological products, she has defined strategies for complex manufacturing changes requiring health agency interpretation. As a creative regulatory strategist, she leads manufacturing sites in implementing changes in record time without disrupting supply. Her track record speaks for itself, having successfully resolved numerous inspection-related queries with major health agencies and implemented effective CAPAs for regulatory compliance. Her global expertise in synthetic, biological, and combination drug-device products in parenteral and solid oral dosage forms is a testament to her capabilities. She is not just a problem solver for quality compliance challenges but also a savvy negotiator with health agencies for product development and marketing. Her expertise in regulatory CMC across the US, EU, JP, CN, and the rest of the world makes her an invaluable partner to R&D, quality, and supply teams.