Head of Regulatory Affairs

Visionary Head of Regulatory Affairs Needed for Pioneering Rare Disease Pharmaceutical Company

Are you passionate about transforming lives through innovative treatments for rare diseases? We need your expertise!

About Us: We're a dynamic, patient-focused 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 looking for 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.

What You'll Do:

• 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

Who You Are:

• 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 understand of global regulatory requirements and processes
• A natural leader who can inspire and develop top talent
• An excellent communicator with a patient-focused mindset

Benefits

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

Ready to lead the charge in bringing hope to those with rare diseases? We want to hear from you!