Vice President, Regulatory Affairs

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Cabaletta Bio

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2017

🧬 Biotechnologie

🏥 Gesundheitswesen

💊 Pharmazie

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio ist ein biotechnologisches Unternehmen in der klinischen Phase, das sich der Entwicklung von modifizierten T-Zell-Therapien zur Behandlung von Autoimmunerkrankungen widmet. Mit der CABA® (Cabaletta Approach to B cell Ablation) Plattform bringt das Unternehmen rese-cel, einen vollständig humanen CD19 CAR T-Zell-Kandidaten mit einem 4-1BB-kostimulatorischen Domäne, in verschiedenen RESET™ Phase 1/2-Studien für systemischen Lupus erythematodes, Myositis, systemische Sklerose, generalisierte Myasthenia gravis und Pemphigus vulgaris voran. Cabaletta strebt an, tiefe, dauerhafte und potenziell kurative Antworten zu liefern, indem B-Zellen vorübergehend eliminiert werden, um die Immuntoleranz zurückzusetzen, und legt Wert auf patientenzentrierte Entwicklung und breitere Indikationserweiterung in den Bereichen Rheumatologie, Dermatologie und Neurologie.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• Competitive benefits • PTO • Stock option plans