Vice President, Regulatory Affairs

🕒 il y a 12 jours

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Cabaletta Bio

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2017

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio est une entreprise de biotechnologie en phase clinique développant des thérapies à base de cellules T modifiées pour traiter les maladies auto-immunes. En utilisant sa plateforme CABA® (Cabaletta Approach to B cell Ablation), la société fait progresser rese-cel, un candidat CD19 CAR T entièrement humain doté d'un domaine co-stimulateur 4-1BB, dans plusieurs essais cliniques RESET™ de phase 1/2 pour le lupus érythémateux systémique, la myosite, la sclérodermie systémique, la myasthénie grave généralisée et le pemphigus vulgaire. Cabaletta vise à offrir des réponses profondes, durables, potentiellement curatives en éliminant temporairement les cellules B pour rétablir la tolérance immunitaire, et met l'accent sur le développement centré sur le patient et l'expansion des indications dans les domaines de la rhumatologie, de la dermatologie et de la neurologie.

Description

• Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization • Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements • Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks • Assess and communicate potential regulatory risks and propose mitigation plans • Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development • Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs, and other relevant submissions to regulatory agencies • Lead strategy for global expedited pathways (e.g. RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US and EU), where applicable • Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing • Build and maintain strong relationships with FDA CBER and other regulatory agencies and represent the company in key regulatory meetings and negotiations • Ensure timely and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice • Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy • Foster a culture of compliance, innovation, and continuous improvement • Coach team members on technical skills and leadership behaviors

🎯 Exigences

• Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred) • 15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization, with at least 8 years in leadership roles • Experience in cell and gene therapy field is preferred • Proven track record of successful IND and BLA submissions (prior BLA experience required) • Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks • Strong leadership, strategic thinking, and negotiation skills • Excellent communication and stakeholder management abilities • Strong team orientation and passion for continuous self-development

🏖️ Avantages

• Competitive benefits • PTO • Stock option plans