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Job Description

OBJECTIVES/PURPOSE:

The individual in this role serves as the enterprise leader accountable for transforming and integrating Site CMC, Regional CMC, Regulatory Conformance, and India Regulatory CMC Operations into a unified global operating model. The role is responsible for enabling compliant, productive, and scalable lifecycle management, strengthening enterprise resilience, advancing regulatory innovation, and establishing India as a world-class strategic hub for Regulatory CMC excellence.
- Define and execute the vision, strategy, and operating model for Site CMC, Regional CMC, Regulatory Conformance, and India Regulatory CMC Operations.
- Embed regulatory conformance within site operations,



establish a biologics Regulatory CMC capability for marketed products in India, and create Centers of Excellence that drive standardization, simplification, operational excellence, and digital transformation across the Regulatory CMC organization.
- Ensure consistent, compliant, and scalable execution enabled through automation and advanced technologies.
- Position India as a strategic global capability center for Regulatory CMC, leveraging exceptional talent, process excellence, digital innovation, and fit-for-purpose governance to deliver lifecycle management, post-approval execution, and regulatory operations at scale while supporting enterprise growth and portfolio expansion.
- Strengthen enterprise regulatory resilience and compliance through science- and risk-based decision-making, proactive regulatory conformance, inspection readiness, and clear accountability across global, regional, local, and site interfa

📌 VP Head, Site (Bengaluru)
🏢 2025 Takeda Biopharmaceuticals India
📍 Bengaluru