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.

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.

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 management in Ireland ensuring compliance with UK and Ireland regulatory requirements. Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
• Support product launch activities
• Review and provide input into promotional materials for both UK and Ireland
• Act as the RA liaison within the UK Leadership team, attend regular meetings and provide input into UK business strategy
• Prepare team for HA interactions, and moderate and lead discussions, be the main MHRA contact for strategic, non-study specific topics and provide support to the EU RA team for clinical matters related to Health Authority topics.
• Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory intelligence, procedures, changes, and trends.
• Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions.
• Ensure compliance with EU/UK global regulatory requirements.
• To lead and mentor junior team members.
• Represent BeOne at UK industrial association meetings and congresses
• Junior Regulatory Affairs professionals

Computer Skills: Extensive experience with Microsoft Office suite, Veeva regulatory publishing and expertise with PowerPoint presentation authoring and presentation.