North American Bio RA Director

Ceva Santé Animale•Lenexa, KS

About The Position

Lead Ceva Animal Health’s North American Product Maximization team and strategy for the biologics portfolio. The role is responsible for product availability, lifecycle growth, regulatory compliance, and execution across licensed products. It partners with Commercial, Manufacturing, Quality, Supply Chain, and Technical Services to maximize product value, expand market access, protect revenue, and ensure uninterrupted supply. The position also provides regulatory and commercial insight to development programs and new product opportunities. As business owner and strategic leader for licensed products, the Director sets direction for lifecycle management, label enhancements, manufacturing changes, market expansion, and regulatory strategies. The role leads and develops a high-performing team, aligns resources with high-value business opportunities, and promotes accountability, customer focus, innovation, and execution excellence. The position is based in Lenexa, Kansas, or in the field, and may require domestic and international travel. It requires the ability to work in an office setting and to read, write, understand, and speak English clearly and effectively.

Requirements

Bachelor’s degree in a related field.
At least 10 years of related experience in the animal health industry, biologics, regulatory portfolio management, or related functions.
Proven leadership experience managing teams and strategic initiatives.
Demonstrable understanding of animal health regulations and product lifecycle management.
Experience influencing senior leadership and leading without direct authority.
Advanced technical skills in developing and executing regulatory affairs strategy.
Knowledge of regulatory affairs legislation and requirements, product procedures, licensing, and documentation management.
Business acumen, networking and influencing, negotiation, communication and presentation, and project and portfolio management skills.
Ability to work in an office setting.
Ability to read, write, understand, and speak English clearly and effectively.
Ability to travel, including internationally, as required.

Nice To Haves

Master’s degree, MBA, DMV, PhD, or equivalent advanced degree.

Responsibilities

Own the strategic direction and execution of regulatory activities for the North American licensed product portfolio, including product priorities, regulatory roadmaps, commitments, and cross-functional decisions about opportunities and risks.
Assess business value, return on investment, and resource needs for regulatory initiatives.
Monitor regulatory changes, assess their impact on portfolio strategy, maintain relationships with authorities and industry stakeholders, participate in trade associations, and provide feedback and foresight to management.
Track competitor activities and regulatory affairs organizations, and encourage effective engagement with authorities to improve responses.
Own lifecycle management for assigned licensed products and maintain multiyear product maximization plans aligned with business objectives.
Prioritize projects by business impact and strategic value, coordinate special projects, manage objectives, and deliver on schedule.
Maintain compliance with regional and national regulatory requirements and lead initiatives that increase product adoption, market penetration, and customer value.
Evaluate opportunities involving new claims, presentations, geographic expansion, manufacturing efficiencies, product modernization, and portfolio rationalization.
Partner with Manufacturing and Supply Chain to resolve product availability constraints, improve business continuity, and proactively manage regulatory and operational risks affecting supply or commercial performance.
Provide long-term regulatory advice to project teams, including guidance on external factors affecting campus portfolios and licenses to operate; address advertising, promotion, and risk communications.
Promote a harmonized dossier preparation strategy within the team and cooperate with other regulatory affairs campuses on dossier approaches and lessons learned.
Serve as the primary escalation point for strategic, operational, and resource challenges affecting portfolio execution.
Lead, develop, and inspire the Product Maximization team; establish accountability, ownership, collaboration, and continuous improvement.
Set team objectives, performance expectations, and development plans aligned with North American and global priorities; recruit, develop, retain, and succession-plan talent.
Coach and mentor team members in regulatory strategy, lifecycle management, project leadership, business acumen, and stakeholder influence.
Allocate resources across licensed product support, lifecycle initiatives, regulatory submissions, and development programs; define and monitor team performance indicators.
Lead workforce planning and manage departmental budgets, resource forecasts, and external consulting expenditures.
Provide regulatory input to development programs and pipeline projects, partnering with R&D, GMSQ, and Marketing to align programs with market needs and business objectives.
Assess commercial viability and lifecycle potential of products in development; identify ways to accelerate future registrations and market adoption.
Guide target product profiles, label development, market positioning, and launch readiness; support due diligence, licensing evaluations, and external innovation opportunities.