Remote UK Regulatory Affairs Director - Oncology

BeiGene, Ltd.; United Kingdom; Remote; GBP 81,000 - 101,000; Full time

Job summary

BeOne is seeking an Associate Director of Regulatory Affairs for the UK & Ireland. The role is fully remote within the UK, leading the UK RA team, shaping MAA strategies, and ensuring UK and Ireland regulatory compliance throughout development and lifecycle management.

The candidate will have extensive MHRA experience, a track record in oncology MAAs, and at least 8 years in regulatory roles within the biopharmaceutical sector. Advanced degree is preferred.

Qualifications

• Minimum of 8 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 8 years’ experience in a Regulatory capacity.
• Experience working with MHRA regulatory procedures is mandatory for this role.
• Strong understanding of UK regulatory requirements and policy trends.
• Experience with oncology products and MAAs is preferred.

Responsibilities

• Lead the UK RA team to manage regulatory aspects of designated compounds through development, registration, post-approval, and lifecycle.
• Define UK MAA strategy aligned with product development objectives.
• Prepare UK MAA dossiers and ensure compliance with UK and Ireland requirements.
• Serve as the UK regulatory liaison within senior leadership and coordinate with EU RA for clinical matters.
• Represent regulatory affairs at meetings and industry associations, and mentor junior staff.

Skills

Regulatory strategy

MHRA experience

Leadership

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree preferred

Tools

Microsoft Office

Veeva regulatory publishing

PowerPoint

Job description

BeOne is seeking an Associate Director of Regulatory Affairs for the UK & Ireland. The role is fully remote within the UK, leading the UK RA team, shaping MAA strategies, and ensuring UK and Ireland regulatory compliance throughout development and lifecycle management.

The candidate will have extensive MHRA experience, a track record in oncology MAAs, and at least 8 years in regulatory roles within the biopharmaceutical sector. Advanced degree is preferred.