Executive Director, Global Regulatory Lead

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Perspective Therapeutics

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2023

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €400 000 Grant en 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics est une entreprise de biotechnologie spécialisée dans le développement de traitements innovants contre le cancer grâce à une classe unique de théranostiques. Leurs technologies exclusives permettent de cibler des tumeurs spécifiques pour le traitement tout en minimisant la toxicité pour les tissus sains. En utilisant la radiation, les radiopharmaceutiques et des technologies d'imagerie avancées, ils visent à améliorer l'efficacité des traitements et à offrir de meilleurs résultats aux patients atteints de cancer.

Description

• Provide strategic regulatory leadership across radiopharmaceutical clinical development programs • Develop and execute global regulatory strategies • Lead global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities • Translate complex and evolving global regulatory requirements into clear, actionable strategies • Ensure regulatory alignment across functions and support the successful advancement of radiopharmaceutical programs from early development through commercialization

🎯 Exigences

• Bachelor’s degree in a scientific or life sciences discipline required; advanced degree (M.S. or Ph.D.) in biology, chemistry, pharmaceutical sciences, engineering, or a related field strongly preferred • Regulatory Affairs Certification (RAC) is a plus • Minimum of 10 years of progressive Regulatory Affairs experience within oncology, specialty therapeutics, and/or complex modalities, with demonstrated regulatory leadership and successful global development outcomes • Experience supporting radiopharmaceutical, oncology, or other complex drug modalities, with a strong understanding of modality‑specific regulatory considerations • Proven track record of leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications, for clinical‑stage and/or commercial products • Extensive experience engaging with global health authorities (e.g., FDA, EMA, and other international agencies)

🏖️ Avantages

• Remote, home-based position • Ability to sit for extended periods of time while working at a computer and participating in virtual meetings • Ability to use standard office equipment, including a computer, phone, and video conferencing tools