Vice President, Regulatory Partnerships

COMPANY DESCRIPTION:A career here is life-enhancing.At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.For more information, visit www.Synergbiopharma.comPOSITION 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.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.KEY RESPONSIBILITIES:Strategic Leadership and Organizational ImpactLead the Regulatory Partnerships function as a core component of an integrated, end-to-end Regulatory Strategy organizationDefine and execute the strategic direction for partnerships, including post-approval and lifecycle management capabilities, ensuring alignment with broader business goalsBuild, lead, and develop a high-performing global team across the United States, India, and evaluate entry into EuropePartner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client-centric solutionsBuilds 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 AcumenDrive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post-approval lifecycle servicesAct as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial teamCollaborate with Commercial and Business Development teams to shape go-to-market strategies and differentiated service offeringsIdentify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long-term partnership modelsMonitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy Client Leadership and Partnership ExcellenceServe as an executive sponsor for key global client relationshipsLead 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 regionsEnsure consistent, high-quality delivery across engagements, with a focus on scalability, predictability, and client satisfactionLeverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships Operational Excellence, Efficiencies, and Continuous ImprovementDrive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnershipsCapture and implement learnings from client engagements to enhance quality, consistency, and speed of deliveryEstablish best practices for global post-approval lifecycle management and submission strategiesPartner with internal teams to optimize resource models, utilization, and delivery effectivenessEmbed a culture of continuous improvement, innovation, and knowledge sharingLeverages data and insights to drive decision-making, continuously refine delivery models, and ensure transparency and alignment across global teams. Technical and Functional ExpertiseProvide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post-approval requirementsGuide teams on complex regulatory strategies across the full product lifecycleMaintain oversight of quality, compliance, and consistency across all client deliverablesContribute to thought leadership, innovation, and advancement of regulatory strategy capabilities Global Leadership and Cultural AgilityLead and develop globally distributed teams, with direct experience across the United States, India, and EuropeDemonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environmentsNavigate the complexities of global client delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contextsAlign global teams to shared goals while respecting regional differences in communication, decision-making, and executionEvaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunitiesFoster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies QUALIFICATIONS & EXPERIENCE:EducationBachelor'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 managementDemonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworksProven experience working within both large pharmaceutical organizations and scientific consulting environmentsTrack record of leading and scaling global teams across the United States, India, and EuropeStrong commercial acumen with demonstrated success in driving revenue growth and expanding client accountsExperience leading complex global client engagements and managing senior stakeholder relationshipsDemonstrated ability to drive operational efficiencies, standardization, and continuous improvementExperience supporting or leading global regulatory partnership models or FSP-style engagements preferredLeadership Profile Strategic, enterprise thinker with the ability to connect regulatory expertise to business growthCommercially driven with strong business and financial acumenClient-focused leader who builds trusted advisor relationshipsCollaborative operator who thrives in a matrixed, global organizationProven people leader with the ability to develop, inspire, and retain high-performing teamsHighly adaptable, with strong executive presence and ability to influence across all levels of the organizationESSENTIAL FUNCTIONS:Physical Demands:The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.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: