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.

Key Responsibilities

• Strategic Leadership and Organizational Impact
  • 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.
• Commercial and Business Acumen
  • 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
  • Maintain a strong commercial acumen, with a focus on driving revenue growth and expanding client accounts
• Client Leadership and Partnership Excellence
  • 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
• Operational Excellence, Efficiencies, and Continuous Improvement
  • 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
  • Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
• Technical and Functional Expertise
  • 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
• Global Leadership and Cultural Agility
  • 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
  • Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies

Qualifications & Experience

• Education: Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field required
• Experience: 15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
• Proven experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
• 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
• Experience driving operational efficiencies, standardization, and continuous improvement
• Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Leadership Profile

• 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

Total Rewards Program

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.