Director Global Regulatory Affairs Lead (m/f/d)

Overview

Job Summary: In this role, you will shape and drive regulatory strategies for biosimilar development and lifecycle management, enabling efficient submissions, approvals, and sustainable product maintenance across global markets. You will own and execute regulatory strategies independently while coordinating cross-functional activities for high-quality submissions. Additionally, you will lead interactions with health authorities, ensure effective implementation of feedback, and proactively influence the evolving regulatory landscape.

Responsibilities

• Provide global regulatory leadership for biosimilar development and manage submission-related documents and data
• Lead preparation, rehearsal and execution of meetings with Health Authorities (e.g. EMA, FDA)
• Develop and drive global submission strategies for biosimilar dossiers across development and lifecycle phases
• Ensure compliance with regulatory requirements across ...