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Job Description

OBJECTIVES/PURPOSE:

The individual in this role is accountable for establishing and scaling India as a critical global regulatory capability center, delivering operational excellence, lifecycle management, regulatory execution, and innovation across the Global CMC Regulatory Affairs organization while building future-ready capabilities that support enterprise growth, portfolio expansion, and regulatory compliance worldwide. Key accountabilities include:
Lead the Global CMC Regulatory Affairs (GRA CMC) India organization, supporting Global, Regional, and Site CMC teams to enable scalable, effective, and compliant execution of post-approval regulatory activities.
Leverage India-based capabilities,



digital solutions, automation, and standardized processes to enhance operational efficiency, quality, consistency, and predictability across lifecycle management activities.
Establish, expand, and continuously optimize CMC RA Centers of Excellence to deliver high-volume regulatory activities, drive process standardization and automation, and foster a culture of continuous improvement.
Serve as a strategic partner across Site, Regional, and Global functions to ensure organizational alignment, regulatory compliance, operational excellence, and effective execution of business priorities.
Build and develop organizational capabilities to assume Marketed Product CMC Regulatory Affairs product leadership responsibilities and support the evolving needs of the global portfolio.
Recruit, develop, and scale biologics regulatory capabilities, initially supporting the Enzyme Replacement Therapy (ERT) and Hematology

📌 Director Global Regulatory Affairs Cmc Bengaluru
🏢 2025 Takeda Biopharmaceuticals India
📍 Bengaluru