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!
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AL Solutions
Since its establishment in 2018, AL Solutions has experienced remarkable growth, specializing in the Life Science Industry
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