Vice President Regulatory Affairs

ARTO; Leeds; On-site; GBP 90,000 - 120,000; Full time

Job summary

A pioneering Bio-MedTech company in the UK is seeking a VP of Regulatory Affairs to define the global regulatory roadmap across multiple jurisdictions. The role involves leading regulatory strategy and scientific dialogue with agencies like MHRA and FDA. Ideal candidates will have experience in biologics and advanced wellness technologies, showcasing a strong track record in regulatory innovation. This is a unique opportunity to contribute to a mission that pushes the boundaries of human health.

Qualifications

• UK-based senior regulatory leader.
• Background in biologics, ATMPs, or advanced wellness.
• Proven track record in regulatory strategy and dialogue.

Responsibilities

• Define the global regulatory roadmap across multiple jurisdictions.
• Lead early scientific dialogue with regulators.
• Build internal regulatory frameworks and quality structures.

Skills

Leadership in regulatory strategy

Knowledge of biologics and ATMPs

Regulatory compliance expertise

Experience with health technologies

Job description

We are supporting an innovative Bio - MedTech company operating at the intersection of advanced therapies, biologics, wellness, and digital health and they are now hiring a VP of Regulatory Affairs.

The role will be required to shape the global regulatory strategy for a fast-growing Bio-MedTech expanding across the UK, EU / Switzerland, US, Middle East and Asia. The role is ideal for a senior regulatory leader who thrives in a pioneering, fast-moving environment and wants to be part of a mission pushing the boundaries of human health and longevity.

Key Responsibilities

• Own and define the global regulatory roadmap across multiple jurisdictions
• Clarify classifications and compliant claims for novel biologics, ATMPs, wellness interventions and digital innovations
• Lead early scientific dialogue with regulators (MHRA, EMA, Swissmedic, FDA and others)
• Build the internal regulatory frameworks, quality structures and documentation standards
• Guide communications, partnerships, and clinical / wellness deployments to remain compliant

Qualifications

• UK-based senior regulatory leader
• Background in biologics, ATMPs, regenerative medicine, advanced wellness, or novel health technologies
• Experience working on boundaries between medical, biological and wellness classifications
• Someone pragmatic, solutions-focused, and comfortable building from scratch in a dynamic environment
• A strong track record leading regulatory strategy, innovation pathways, or early regulatory dialogue

If your interested, or know someone who might be, reach out to me at :

[e-mail]