VP Head, Site & Regional, Regulatory CMC – India.
BengaluruFull-time15–20 yrsPosted 3 weeks ago
Leadership legal role at Takeda Pharmaceutical in Bengaluru. Needs 15–20 years and a PhD.
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
- Compliance
- Talent management
- Regulatory affairs
- Documentation
- Performance management
Good to have
- Negotiation