Regulatory Strategy Lead

Regulatory Strategy Lead for global drug development projects, providing senior regulatory and integrated project leadership, with deep hands-on expertise in US and EU regulatory strategy and delivery. Key responsibilities include authoring and delivering key regulatory submissions, leading cross-functional development activities, and driving high-quality, compliant, and executable development strategies across the product lifecycle.

Requirements

• Acts as Project Lead for development projects
• Provides end-to-end project leadership
• Serves as Regulatory Lead for assigned projects
• Leads and authors core regulatory strategy documents
• Acts as the primary client point of contact
• Leads cross-functional matrix teams
• Owns project-level planning and execution
• Accountable for project budgets and resourcing
• Leads preparation for and facilitation of governance forums
• Anticipates regulatory and development risks
• Contributes to business development activities
• Mentors junior colleagues and Project Leads