Cabaletta Bio · 1 hour ago
Vice President, Regulatory Affairs
All, MO
Full-time
Hybrid
Director/Executive
15+ years expCabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The Vice President of Regulatory Affairs will lead the global regulatory strategy and execution for advanced cell therapy product development, ensuring compliance with regulations and guiding interactions with health authorities.
BiotechnologyHealth CareMedicalRoboticsTherapeutics
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience in cell and gene therapy field is preferred
Benefits
Competitive benefits
PTO
Stock option plans
Company
Cabaletta Bio
Cabaletta Bio has adapted clinically-validated and FDA-approved CAR T cell technology to target B cell-mediated autoimmune diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$310MKey Investors
5AM Ventures
2025-06-11Post Ipo Equity· $100M
2023-05-17Post Ipo Equity· $87M
2022-12-08Post Ipo Equity· $35M
Leadership Team
Samik Basu
Chief Scientific Officer
Steve Gavel
Chief Commercial Officer
Recent News
GlobeNewswire
2026-01-12
2025-12-11
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