At a Glance
- Tasks: Drive regulatory strategies in neuroscience to help innovative treatments reach patients faster.
- Company: Join Novartis, a leader in healthcare with a commitment to diversity and inclusion.
- Benefits: Enjoy competitive rewards, a hybrid work model, and opportunities for personal and professional growth.
- Other info: Collaborative environment with a focus on innovation and community.
- Why this job: Make a real impact in healthcare by supporting groundbreaking neuroscience programs.
- Qualifications: Experience in regulatory affairs and strong project management skills are essential.
The predicted salary is between 60000 - 80000 £ per year.
This job is with Novartis, an inclusive employer. Work Arrangement: Hybrid Location: London, United Kingdom. Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.
ABOUT THE ROLE
Drive regulatory execution that enables innovation in neuroscience to reach patients faster. As Regulatory Affairs Manager - Neuroscience, you will play a key role in delivering regulatory strategies across assigned regions, ensuring high-quality submissions and effective interactions with Health Authorities. Working cross-functionally, you will translate complex scientific and clinical data into regulatory deliverables, supporting timely approvals and maintaining compliance throughout the product lifecycle. This role offers the opportunity to build deep regulatory expertise while contributing to impactful global programs in a dynamic and collaborative environment.
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. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
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.
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
Global Program Regulatory Manager - Neuroscience employer: Novartis
Novartis is an exceptional employer that fosters a dynamic and inclusive work culture, particularly in the vibrant city of London. With a strong commitment to diversity and employee growth, Novartis offers robust benefits and opportunities for professional development, allowing you to thrive while contributing to meaningful advancements in neuroscience. Join a collaborative team dedicated to reimagining medicine and making a real impact on patients' lives.
