Georgette Kokinda
Executive Director, Global Regulatory Affairs, Global Labeling Strategy Therapeutic Areas @Takeda
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WORK HISTORY
Executive Director, Global Regulatory Affairs, Global Labeling Strategy Therapeutic Areas @Takeda
EDUCATION
Harvard Medical School
Executive Education, Executive Program for Senior Life Science Leaders
University of Scranton
Bachelor of Science - BS, Biochemisty
SKILLS
ABOUT GEORGETTE KOKINDA
Executive Leadership in Global Labeling Strategy: • Lead and manage the strategic aspects of product labeling across all therapeutic areas at Takeda. • Ensure alignment between regulatory labeling strategies and the company’s global business objectives.Regulatory Expertise & Industry Best Practices: • Leverage extensive experience in regulatory labeling across vaccines, oncology, rare diseases, neuroscience (NS), and gastrointestinal (GI) products. • Drive compliance with global and local regulatory requirements while integrating the latest scientific and clinical data into prescriber and patient labeling. • Ensure product labeling directly impacts patient safety, healthcare provider understanding, and global market success.Leadership & Oversight of Global Labeling Leads (GLLs): • Provide strategic direction and leadership to GLLs, who manage cross-functional collaboration across clinical development, medical affairs, pharmacovigilance, and marketing. • Ensure high-quality, compliant labeling content delivery that meets complex regulatory standards. • Guide teams through negotiations with regulatory authorities, addressing critical labeling-related questions and challenges.Alignment of Labeling Strategy with Business Goals: • Deliver labeling solutions that advance both patient outcomes and stakeholder value. • Maintain a proactive, future-focused approach to regulatory labeling strategy, ensuring continuous alignment with evolving global regulatory landscapes. • Foster collaboration across internal and external stakeholders to drive strategic initiatives and operational excellence.
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