North American Bio RA Director

About the role

Ceva is looking for a North American Bio RA Director to lead the Product Maximization team and strategy for its biologics portfolio. The role ensures product availability, lifecycle growth, regulatory compliance and execution excellence across licensed products, working with Commercial, Manufacturing, Quality, Supply Chain and Technical Services. It is based in Lenexa, KS, or as a field position.

Key responsibilities

• Own the regulatory strategy and execution for the North American licensed product portfolio, including roadmaps, priorities and timely regulatory commitments
• Build and maintain relationships with regulatory authorities, trade associations and industry stakeholders, and share regular feedback with management
• Lead lifecycle management for assigned products, including multi-year maximization plans, new claims, presentations, geographic expansion, manufacturing efficiencies and portfolio rationalization
• Coordinate with Manufacturing and Supply Chain to resolve product availability constraints and plan for regulatory and operational risks
• Ensure harmonized regulatory dossier preparation and act as escalation point for strategic, operational and resource challenges
• Lead and develop a high-performing Product Maximization team, set objectives, coach and mentor, recruit and succession-plan, and define KPIs
• Manage departmental budgets, resource forecasting and external consulting expenditures
• Provide secondary support to new product development, including regulatory input, target product profiles, label development and launch readiness

Required profile

• Bachelor's degree in a related field required
• Master's degree, MBA, DMV, PhD or equivalent preferred
• Advanced technical skills in regulatory affairs strategy, legislation and requirements, product and procedures documentation, and project and portfolio management