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Regulatory Affairs Director

hace 2 meses

Madrid, Madrid, España Al Solutions A tiempo completo
Transform Lives through Innovative Treatments

We're a pioneering rare disease pharmaceutical company dedicated to developing groundbreaking therapies for orphan conditions. Our mission is to bring hope and life-changing treatments to those affected by rare diseases.

The Opportunity

We're seeking an exceptional Head of Regulatory Affairs to join our leadership team and drive our regulatory strategy forward. This is your chance to make a real difference in the lives of patients worldwide.

Key Responsibilities
  • Spearhead our global regulatory strategies across our innovative product portfolio
  • Lead crucial interactions with regulatory authorities, including FDA, EMA, and others
  • Oversee regulatory filings from INDs to NDAs and MAAs
  • Build and mentor a high-performing regulatory affairs team
  • Collaborate with our clinical, medical, and commercial teams to drive success
  • Keep us ahead of the curve on evolving regulatory landscapes, especially in rare diseases
  • Provide valuable regulatory insights to support our business growth
Requirements
  • A regulatory affairs expert with an advanced degree in Life Sciences or Pharmacy
  • A seasoned professional with 10+ years in Regulatory Affairs, including 5+ years leading teams
  • A strategic thinker with a track record of successful regulatory approvals, particularly in orphan drugs
  • An in-depth understanding of global regulatory requirements and processes
  • A natural leader who can inspire and develop top talent
  • An excellent communicator with a patient-focused mindset
What We Offer
  • The opportunity to directly impact patients' lives through your work
  • Competitive compensation and comprehensive benefits
  • A collaborative, innovative environment where your ideas matter
  • Clear paths for professional growth and development
  • Flexible working arrangements for a healthy work-life balance