Georgette Kokinda

Executive Director, Global Regulatory Affairs, Global Labeling Strategy Therapeutic Areas @Takeda

Boston, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2024 — Present

Executive Director, Global Regulatory Affairs, Global Labeling Strategy Therapeutic Areas @Takeda

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EDUCATION

2025 — 2025

Harvard Medical School

Executive Education, Executive Program for Senior Life Science Leaders

N/A

University of Scranton

Bachelor of Science - BS, Biochemisty

SKILLS

Regulatory SubmissionsDrug DevelopmentU.s. Title 21 Cfr Part 11 RegulationBiopharmaceuticalsBiotechnologyRegulatory AffairsPharmaceutical IndustrySopFda21 Cfr Part 11Quality SystemVaccinesTherapeutic AreasU.s. Food and Drug Administration (Fda)Infectious DiseasesClinical TrialsStandard Operating Procedure (Sop)Medical DevicesClinical DevelopmentGmpLife Sciences

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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Georgette Kokinda — Executive Director, Global Regulatory Affairs, Global Labeling Strategy Therapeutic Areas at Takeda in Boston, MA, US | Unifers