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Antonella Lozito, PharmD

Vice President, Global Regulatory Strategy
Moderna

Antonella Lozito, PharmD, currently serves as a Vice President, Global Regulatory Strategy and U.S. Regulatory Policy and Intelligence at Moderna. In this dual role, Antonella leads the development and execution of U.S. regulatory policy, intelligence, and health authority engagement strategies to advance Moderna’s mRNA pipeline. Throughout her time at Moderna, Antonella has held global regulatory strategic oversight of registration and lifecycle management of Moderna’s respiratory vaccines, including COVID-19 mRNA vaccines, and advancement of mRNA technology to Oncology, Rare and Autoimmune therapeutics, Latent and Global Public Health vaccines.

With over 20 years of experience in global regulatory affairs, Antonella is recognized for having strategically led and executed project and portfolio strategies across a diverse range of therapeutic areas. With specialized expertise in small molecules, biologics, and gene therapies, Antonella has contributed to the development of oncology, psychiatry, neurology, dyslipidemia, endocrinology, immunology, dermatology, rare blood disorders, and vaccine programs. Antonella’s leadership extends to global regulatory interactions and milestones with major health authorities, including the FDA, EMA, Health Canada, MHRA, PMDA, and other national agencies. She has guided regulatory strategies from preclinical and clinical development stages (IND/CTA applications) through to regulatory submissions and post-approval lifecycle management (NDA/BLA/MAA), ensuring products reach patients in multiple geographies.

Antonella has consistently driven organizational success through strategic leadership, talent development, and regulatory excellence. She has led restructuring efforts to optimize workflows, enhance cross-functional collaboration, and streamline regulatory processes. Her focus on talent acquisition and capability building has strengthened teams by recruiting top professionals and implementing impactful training programs. Additionally, she has fostered alliances with external partners, ensuring aligned regulatory strategies across therapeutic areas. As a mentor and leader, Antonella has cultivated a collaborative and growth-oriented environment, empowering teams to excel in innovation and professional development.

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