Job Purpose

This role leads all CTA submission activities for new assets and pipeline products, ensuring timely and compliant regulatory submissions through effective stakeholder management and strategic planning to accelerate access to innovative therapies. While the primary focus of this role is CTA submission leadership, the position also provides support to regulatory compliance and Quality Risk Management (QRM) activities within LOC RA, with opportunities to collaborate on governance and continuous improvement initiatives.

This role reports to directly to RA Head, but not a people manager.

Key Responsibilities

Regulatory Submission Management (CTA Expertise)