Regulatory Affairs Director

This role involves leading and developing a team by managing performance, resources, and employee relations while ensuring alignment with organizational policies and regional/global strategy. The individual oversees workload, quality, and team effectiveness, collaborates cross-functionally to address operational challenges, and drives the implementation of strategic initiatives. They hold full financial accountability for one or more Regulatory Affairs sites, including performance monitoring and risk management, and may lead complex projects or provide strategic regulatory consultancy. Additionally, the role includes engaging with regulatory authorities, contributing to business development activities such as bid defense, and representing the organization through presentations and thought leadership in the field.

The candidate should have 8+ years of regulatory affairs experience (including 6+ years in management) within pharma or a CRO, with proven success in leading and developing senior teams. They bring strong leadership, influencing, and negotiation skills, can navigate complex stakeholder environments, and effectively communicate and drive regulatory strategy while remaining resilient under pressure.