Vice President Regulatory Affairs

ARTO
Birmingham
2 months ago
Applications closed

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Head of Scientific and Regulatory Affairs

Head of Scientific and Regulatory Affairs

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 :



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