VP Head, Site & Regional, Regulatory CMC – India.

About the role

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.

What you'll do

• 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
• 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
• Strengthen enterprise regulatory resilience and compliance through science- and risk-based decision-making, proactive regulatory conformance, inspection readiness

What you need

• 15–20 yrs of experience
• Compliance
• Talent management
• Regulatory affairs
• Documentation
• Performance management
• PhD

Good to have

• Negotiation