Regulatory Affairs Product Maximizer Director

Location: Lenexa, KS or Field Job Summary and Purpose: Lead the North American Product Maximization team and strategy for the biologics portfolio by ensuring product availability, lifecycle growth, regulatory compliance, and execution excellence across licensed products. Partner with Commercial, Manufacturing, Quality, Supply Chain, and Technical Services to identify and execute opportunities that maximize product value, expand market access, protect revenue streams, and ensure uninterrupted supply. Build and lead a high-performing team responsible for licensed product lifecycle management, regulatory execution, portfolio optimization, and selected development support activities. Foster a culture of accountability, customer focus, innovation, and execution excellence while ensuring resources are aligned with the highest-value business opportunities. Serve as the business owner and strategic leader for licensed products, providing direction on lifecycle management, label enhancements, manufacturing changes, market expansion opportunities, and regulatory strategies that support business growth. Additionally, contribute regulatory and commercial insight to development programs and new product opportunities to ensure future portfolio success. Responsibilities and Key Duties: Licensed Product Regulatory Strategy Execution Own the strategic direction and execution of regulatory activities supporting the North American licensed product portfolio. Establish product priorities and regulatory roadmaps that maximize product value, market access, and revenue growth. Lead cross-functional decision making regarding regulatory opportunities and risks. Ensure timely execution of regulatory commitments required to maintain product licenses and support business objectives. Assess business value, return on investment, and resource requirements associated with regulatory initiatives. Regulatory Responses and Interaction with Authorities : Monitor emerging regulatory changes and assess impacts on portfolio strategy. Build and maintain contact with the Authorities. Balance the risk vs quality. Be a member of trade associations. Share regular feedback to management teams. Build maintain good relationships and provide foresight, co-ordination of activities needed to influence regulatory decisions for the interest of Ceva through internal and external network (trade associations, regulatory authorities in country region of origin of the campuses). Allocate capacity and budget to join public organizations to improve network with authorities and industry stakeholders. Keep track on competitors' activities and RA organizations. Encourage the team to improve contact authorities to increase the efficiency of the responses. Lifecycle Management Product Optimization Own lifecycle management strategy for all assigned licensed products. Develop and maintain multiyear product maximization plans aligned with business objectives. Drive prioritization of projects based on business impact and strategic value. Coordinate special projects and manage the objectives with effective and problem-solving approach. Respect timings. Maintain consistently high standards and achieve compliance with regional and national regulatory requirements. Lead initiatives that increase product adoption, market penetration, and customer value. Evaluate opportunities for: New claims, New presentations, Geographic expansion, Manufacturing efficiencies, Product modernization, Portfolio rationalization. Partner with Manufacturing and Supply Chain to resolve product availability constraints and improve business continuity. Drive proactive planning for regulatory and operational risks that could impact product supply or commercial performance. Ensure regulatory product compliance to protect supply of campus products for business continuity. Regulatory Dossier and Compliance : Ensure strategic long-term regulatory advice to project teams to help shape the future of campus portfolio and to manage the external impact influencing the campus license to operate. Advertising, promotion and risk communications. Guarantee a harmonized dossier preparation strategy among the team and extend the cooperation with other RA campuses for harmonization of dossier content approach and lessons learned. Serve as the primary escalation point for strategic, operational, and resource-related challenges impacting portfolio execution. Team Leadership Organizational Development Lead, develop, and inspire a high-performing Product Maximization team focused on delivering portfolio growth, regulatory execution, and business continuity. Establish a culture of accountability, ownership, collaboration, and continuous improvement aligned with Ceva values and leadership principles. Set clear objectives, performance expectations, and development plans for team members while ensuring alignment with North American and global business priorities. Recruit, develop, retain, and succession-plan talent to support current and future portfolio needs. Coach and mentor team members in regulatory strategy, lifecycle management, project leadership, business acumen, and stakeholder influence. Ensure appropriate allocation of resources across licensed product support, lifecycle management initiatives, regulatory submissions, and development programs. Create an engaging work environment that promotes innovation, cross-functional collaboration, and professional growth. Define key performance indicators and monitor team effectiveness, productivity, and business impact. Lead workforce planning activities to maintain organizational capabilities aligned with portfolio priorities and future growth opportunities. Manage departmental budgets, resource forecasting, and external consulting expenditures in accordance with company objectives. New Product Development Support (Secondary Responsibility) Provide regulatory input to development programs and pipeline projects. Partner with R D, GMSQ and marketing teams to ensure development programs align with market needs and business objectives. Assess commercial viability and lifecycle potential of new products under development. Identify opportunities to accelerate future registrations and market adoption. Provide strategic guidance regarding target product profiles, label development, market positioning, and launch readiness. Support due diligence activities, licensing evaluations, and external innovation opportunities. Positioning of Responsibilities: 40% Licensed Product Lifecycle Management Maximization 25% Regulatory Execution Product Compliance 15% Team Leadership Talent Development 10% Portfolio Strategy Business Performance 10% New Product Development Support Innovation Core Competencies: · Shape solutions out of complexity · Client focus · Collaborate with empathy · Engage and develop · Drive ambition and accountability · Influence others Technical / Functional Competencies: · Advanced levels of Technical Skills for: o Development and execution of Regulatory Affairs Strategy o Regulatory Affairs legislation and requirements knowledge o Product Procedures/Licensing documentation management knowledge o Business Acumen o Networking influencing - Negotiating o Communication presentation skills o Project Portfolio Management Qualifications: Education – Bachelor’s degree in related field required. Master’s degree, MBA, DMV, PhD or equivalent advanced degree strongly preferred. Work Experience – 10+ years of related experience in animal health industry, biologics, regulatory portfolio management, or related functions, including proven leadership experience managing teams and strategic initiatives with a demonstrable understanding of animal health regulations and product lifecycle management. Proven experience influencing senior leadership and leading without direct authority is also required. Working Conditions: Ability to work in an office setting. Ability to read, write, understand and speak English clearly and effectively. Travel Required: This position may require travel, including international travel This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.