Regulatory Specialist and Senior Specialist - London, United Kingdom - AstraZeneca GmbH

Description

Regulatory Affairs Specialist – CVRM
Competitive Salary and Benefits

Join our CVRM Regulatory Team as a Regulatory Affairs Specialist and embrace the opportunity to shape the future of healthcare.

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.

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.

UK Regulatory experience
Ability to work independently on regulatory submissions and approvals throughout the product lifecycle in a timely manner
Experience with compliance systems
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