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

Job Purpose:

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. 

Your 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 key markets (EU, US, Canada, Switzerland, Brazil)  

• Align and gain endorsement of regulatory strategies with Development Team and Biosimilar Management Team (BMT)  

• Define and deliver clear regulatory storylines for authority interactions (e.g. briefing books, submissions)  

• Collaborate with Regulatory Operations to implement technologies and ensure consistent systems and processes  

• Provide regulatory guidance to Market Units and support global launch and market prioritization decisions  

• Lead the Regulatory Sub-team and drive submissions through to approval, including readiness assessments  

• Act as key interface across regulatory and cross-functional teams, mentor team members and manage external partners