Director, Regulatory Affairs - UK & Ireland

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Director of Regulatory Affairs will be responsible for developing and implementing UK regulatory strategies for development programs to secure and maintain the marketing authorization for product(s) in line with business objectives, and in coordination with key internal stakeholders. This will also include oversight and management of commercial products for both UK and Ireland..

Essential Functions Of The Job

This individual will lead the UK RA team to manage regulatory aspects of designated compounds (NME/New indications) through all phases of development, registration, post-approval, and lifecycle of the product as detailed below:

Collaborate with key internal stakeholders to develop, implement and maintain regulatory strategies for new product submissions, including MAAs, and oversee the regulatory aspects of early-stage development programmes in line with global product development objectives and UK business goals.

• Manage the content of and prepare regulatory (UK MAA) dossiers. Have knowledge of the content of the EU MAA dossiers to support labeling updates and manage...

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