Vice President, Regulatory Partnerships

Position Overview

The Vice President, Regulatory Partnerships is a senior leadership role within the end‑to‑end Regulatory Strategy organization, spanning preclinical, clinical, Regulatory CMC, Regulatory Operations, and Regulatory Partnerships. This role is responsible for leading and expanding strategic regulatory partnerships, with a strong emphasis on post‑approval lifecycle management, driving integrated client solutions, and accelerating commercial growth.

• Lead the Regulatory Partnerships function as a core component of an integrated, end‑to‑end Regulatory Strategy organization
• Define and execute the strategic direction for partnerships, including post‑approval and lifecycle management capabilities, ensuring alignment with broader business goals
• Build, lead, and develop a high‑performing global team across the United States, India, and evaluate entry into Europe
• Partner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client‑centric solutions
• Build a culture of rigor and accountability by establishing clear performance metrics, KPIs, and standardized processes across regulatory partnerships, enabling consistent measurement of delivery quality, efficiency, and client outcomes

• Drive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post‑approval lifecycle services
• Act as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial team
• Collaborate with Commercial and Business Development teams to shape go‑to‑market strategies and differentiated service offerings
• Identify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long‑term partnership models
• Monitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy

• Serve as an executive sponsor for key global client relationships
• Lead and manage strategic client partnerships with a focus on long‑term lifecycle support, including post‑approval activities (variations, supplements, global submissions)
• Build and sustain value‑driven relationships with senior client stakeholders across regions
• Ensure consistent, high‑quality delivery across engagements, with a focus on scalability, predictability, and client satisfaction
• Leverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships

• Drive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnerships
• Capture and implement learnings from client engagements to enhance quality, consistency, and speed of delivery
• Establish best practices for global post‑approval lifecycle management and submission strategies
• Partner with internal teams to optimize resource models, utilization, and delivery effectiveness
• Embed a culture of continuous improvement, innovation, and knowledge sharing
• Leverage data and insights to drive decision‑making, continuously refine delivery models, and ensure transparency and alignment across global teams

• Provide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post‑approval requirements
• Guide teams on complex regulatory strategies across the full product lifecycle
• Maintain oversight of quality, compliance, and consistency across all client deliverables
• Contribute to thought leadership, innovation, and advancement of regulatory strategy capabilities

• Lead and develop globally distributed teams, with direct experience across the United States, India, and Europe
• Demonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environments
• Navigate the complexities of global client…