Regulatory Affairs Specialist

Regulatory Affairs Specialist – CVRM

Location: London

Competitive Salary and Benefits

Closing date: 5th May 2024

Introduction to Role:

Join our CVRM Regulatory Team as a Regulatory Affairs Specialist and embrace the opportunity to shape the future of healthcare. Be part of changing the practice of medicine forever. In this role, you will deliver and maintain competitive licenses for UK commercial brands, ensuring regulatory compliance for defined product and project responsibilities, including project leadership. You will also be responsible for the timely delivery of clinical trial approvals and maintaining high regulatory compliance standards for the UK.

Accountabilities:

As a Regulatory Affairs Specialist, you will ensure timely submission and approvals of all licensing applications and compliance with UK regulatory requirements. You will provide regulatory input to stock and supply issues, manage pack changes, ensure labelling compliance, and develop professional working relationships with assessors and administrative staff within the regulatory agencies. You will also prepare high-quality regulatory applications and responses for the UK, defend existing labelling, and contribute to cross-functional team working within the Medical & Regulatory Department and other areas of the business.

As a Regulatory Specialist you will also manage the CVRM team finance activities e.g. tracking invoices, making payments etc in addition to other organisational tasks that support the wider team.

You will be reporting to the Regulatory Affairs TA lead and work in close collaboration with Regulatory Managers and Specialists within CVRM and across different TAs.

Essential Skills/Experience:

• UK Regulatory experience
• Ability to work independently on regulatory submissions and approvals throughout the product lifecycle in a timely manner
• Drive meaningful interactions with cross-functional teams within the UKMC as well as the Global team
• Demonstrable negotiation skills
• Good understanding of drug development processes
• Ability to make optimal use of IT systems

Desirable Skills/Experience:

• Experience with compliance systems
• Initiative to contribute to the optimisation and continuous improvement of current ways of working

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

If you are inspired by the possibilities of science to make a difference and ready to discover what you can do by joining us on this exciting journey and believe you can contribute to this bold ambition – join us!

Where can I find out more?

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