Regulatory Affairs Manager - Leading Global Biopharma | UK Your new company
Our client, a leading global biopharmaceutical organisation, is dedicated to advancing science and improving patient lives. With people at the heart of every decision, they are committed to ensuring patients today and for generations to come receive the treatments they need.We are supporting them in the search for an exceptional Regulatory Affairs Specialist to join their UK organisation and play a pivotal role in shaping strategic regulatory initiatives.
Your new role
As a Regulatory Partner, you will be a key member of the UK Regulatory function, providing expert guidance and strategic direction across a broad portfolio. You'll collaborate cross-functionally to influence policy, accelerate access to innovative medicines, and ensure the company maintains a strong licence to operate in the UK.This is a unique chance to make a tangible impact on patient outcomes within a mission driven, science led environment.
Working within the UK Regulatory Group, you will:
Navigate and translate evolving UK regulatory requirements into business ready solutions.
Lead or support:
Clinical Trial Applications
National Licencing Applications
Early Access to Medicines submissions
National components of centralised EU procedures
Act as a primary point of contact with the MHRA, representing the organisation externally with credibility and influence.
Partner with internal teams at both local and global levels to shape strategy and maintain compliance.
Identify opportunities within a shifting regulatory landscape and support continuous improvement.
What you'll need to succeed
A passionate regulatory professional with a strong UK regulatory background and a desire to contribute to better patient outcomes. You will bring:
A scientific degree (or equivalent experience).
Extensive experience in UK Regulatory Affairs.
Proven experience managing UK submissions in the post-Brexit environment.
Strong knowledge of UK and EU regulatory processes.
Experience providing strategic and technical regulatory advice.
A track record of developing and delivering regulatory strategies.
Excellent documentation and submission quality skills.
Experience as a Subject Matter Expert (SME) in relevant therapeutic or regulatory areas.
Confidence in mentoring peers and managing cross-functional stakeholder relationships.
What you'll get in return
Places patients at the centre of everything they do.
Encourages autonomy, collaboration, and innovation.
Invests in the growth and development of its people.
Offers the chance to influence national regulatory strategy and drive meaningful change across the UK healthcare ecosystem.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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