Vice President, Regulatory Affairs - All - Cabaletta Bio

Description

Cabaletta Bio (Nasdaq: CABA) is a clinical‑stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases. The CABA platform has two complementary strategies designed to advance the discovery and development of engineered T‑cell therapies for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy prioritizes rese‑cel, a 4‑1BB‑containing fully human CD19‑CAR T‑cell investigational therapy being evaluated in the RESET (REstoring SElf‑Tolerance) program across rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, visit and connect on LinkedIn.

Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the mission of developing cures using patients' own cells. We build a culture focused on team success and continuous growth. We are proud to be a Great Place to Work‑Certified company.

Position Description

This role can be remote or based out of our Philadelphia, PA headquarters. Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs will drive global regulatory strategy and execution for an advanced cell therapy product development program, ensuring compliance with all applicable regulations and guiding interactions with health authorities (FDA, EMA, and other global agencies).

Key Responsibilities

Strategic Leadership

• 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.

Regulatory Submissions & Compliance

• 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.

Regulatory Interactions

• 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.

Team Leadership

• Build and manage a high‑performing regulatory affairs, operations, writing, and CMC regulatory team 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.

Qualifications

• 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 the 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.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development.

For more information, visit our careers page at

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, employment agency, or staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, or firm.