Dr Nivedita Roy

Vice President Regulatory Science & Policy at Alvotech

Speaker

Dr. Nivedita Roy is a global regulatory science leader with over 20 years of experience in biologics and biosimilars development across major markets, including the FDA (US), EMA (EU), PMDA (Japan), Health Canada, and other international agencies. As Vice President and Global Head of Regulatory Science & Policy at Alvotech, she leads global regulatory strategy spanning CMC, clinical, non-clinical, labeling, and lifecycle management to enable worldwide approvals and commercialization of complex biologics.Dr. Roy has led more than 50 health authority interactions, including extensive engagements with the FDA and EMA, and has contributed to over 20 successful BLAs, MAAs, and JNDAs. She actively represents industry in international regulatory policy discussions, including contributions to ICH guidance development.