Global Program Regulatory Manager - Neuroscience

Key Responsibilities 

• Implement regulatory strategy and manage operational activities across assigned regions 

• Support development of global regulatory strategy and identify risks or gaps for assigned regions 

• Partner with regional teams to align regulatory plans and ensure effective execution 

• Lead preparation of Health Authority interactions, including briefing documents and response plans 

• Drive coordination and submission of regulatory dossiers across assigned regions 

• Review, approve, and submit Clinical Trial Applications and Investigational New Drug applications 

• Manage responses to Health Authority queries and support timely approvals while minimising delays 

 
Essential Requirements 

• Experience in regulatory affairs within pharmaceutical or biotechnology environments 

• Knowledge of regulatory submission processes and compliance requirements 

• Experience supporting regulatory strategy and execution across multiple regions 

• Strong project management and organisational skills in a matrix environment 

• Ability to collaborate with cross-functional teams and external stakeholders 

• Strong problem-solving skills and attention to detail in regulatory decision-making 

• Effective communication skills and ability to interpret and present technical information clearly