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 

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network