Director, Global Regulatory Affairs

We are looking for a Director, Global Regulatory Affairs to define and execute global regulatory strategies for oncology programmes. Lead cross-functional teams, manage regulatory submissions, and ensure compliance with health authorities. Ideal for experienced regulatory professionals with a strong background in oncology and leadership.

Skills

• regulatory quality standards
• risk management
• regulatory submissions (ectd/dossier delivery)
• regulatory data-driven decision making
• regulatory horizon analysis
• regulatory strategy influence
• regulatory program management
• health authority interaction (fda, ema, hra)
• regulatory submissions
• regulatory lifecycle management
• regulatory strategy development
• stakeholder management
• regulatory compliance
• regulatory change management
• project management
• cross-functional team leadership
• regulatory risk assessment
• oncology regulatory expertise