Marina Carbonari is a seasoned regulatory affairs professional with over 20 years of diverse experience in the pharmaceutical industry, currently serving as the Senior Manager of Global Regulatory Affairs at EMD Serono, Inc. In her role, Marina plays a pivotal part in shaping regulatory strategies...
Marina Carbonari is a seasoned regulatory affairs professional with over 20 years of diverse experience in the pharmaceutical industry, currently serving as the Senior Manager of Global Regulatory Affairs at EMD Serono, Inc. In her role, Marina plays a pivotal part in shaping regulatory strategies that align with both corporate objectives and compliance mandates. Her extensive background as a pharmacist, combined with an MBA in Business Management, equips her with a unique perspective that bridges scientific rigor and business acumen.
At EMD Serono, Marina is the Regulatory US Lead for Investigational New Drug (IND) submissions, where she collaborates closely with cross-functional development teams to ensure that all regulatory requirements are met efficiently and effectively. Her expertise extends to serving as the Country Regulatory Affairs representative for the U.S. within Global Regulatory teams, providing critical insights on assigned marketed products. This role requires her to coordinate and lead interactions with the FDA, a responsibility that underscores her strong communication skills and in-depth knowledge of regulatory frameworks.
Marina's key projects often involve the review and preparation of complex regulatory documents, where her meticulous attention to detail and understanding of Good Manufacturing Practices (GxP) come into play. She is adept at navigating the intricacies of pharmaceutical research and development, ensuring that all submissions are not only compliant but also strategically positioned for successful market entry. Her skills in trend analysis and change control further enhance her ability to anticipate regulatory challenges and implement proactive solutions, making her an invaluable asset to the EMD Serono team. Through her leadership, Marina continues to drive innovation and regulatory excellence, contributing to the advancement of therapies that improve patient outcomes.
