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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