Vice President, Regulatory Partnerships

Syner-G•Boston, MA

12h•Remote

About The Position

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. This leader will play a pivotal role in shaping how regulatory services are delivered across the organization by connecting scientific expertise with strategic advisory and execution, while positioning the company as a trusted partner to global pharmaceutical and biotech clients. A key focus of the role will be optimizing post-approval strategies, enhancing client delivery models, driving efficiencies, and embedding continuous improvement across engagements.

Requirements

Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field
15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
Demonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
Proven experience working within both large pharmaceutical organizations and scientific consulting environments
Track record of leading and scaling global teams across the United States, India, and Europe
Strong commercial acumen with demonstrated success in driving revenue growth and expanding client accounts
Experience leading complex global client engagements and managing senior stakeholder relationships
Demonstrated ability to drive operational efficiencies, standardization, and continuous improvement
Strategic, enterprise thinker with the ability to connect regulatory expertise to business growth
Commercially driven with strong business and financial acumen
Client-focused leader who builds trusted advisor relationships
Collaborative operator who thrives in a matrixed, global organization
Proven people leader with the ability to develop, inspire, and retain high-performing teams
Highly adaptable, with strong executive presence and ability to influence across all levels of the organization

Nice To Haves

Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Responsibilities

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
Builds 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
Leverages 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 delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contexts
Align global teams to shared goals while respecting regional differences in communication, decision-making, and execution
Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies