VP Head, Site & Regional, Regulatory CMC – India.
Core
Enterprise leader accountable for transforming and integrating Site CMC, Regional CMC, Regulatory Conformance, and India Regulatory CMC Operations into a unified global operating model.
Role type
VP Head, Site & Regional, Regulatory CMC
Builds
Unified global operating model for Regulatory CMC operations
Domain
Biopharmaceuticals / Regulatory Affairs / CMC
Required skills
Global CMC regulatory strategy, lifecycle management, regulatory conformance, organizational transformation, talent acquisition, succession planning, governance framework design, digital transformation, risk-based decision-making, stakeholder influence
Preferred skills
Experience establishing science- and risk-based assessment frameworks, Centers of Excellence development, automation and digital innovation
Technologies
Automation tools, digital transformation platforms
Responsibilities
Define and execute vision and strategy for Site CMC and India Regulatory CMC operations; Embed regulatory conformance within site operations; Lead large-scale organizational transformation and capability development; Represent Global Regulatory Affairs and CMC on enterprise governance forums; Build and sustain a world-class organization; Establish India as a strategic global capability hub for Regulatory CMC
Seniority
VP, Enterprise Leadership