Director, Regulatory

Director, Regulatory Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be remote or based out of our Philadelphia, PA headquarters . We are seeking an experienced and highly motivated professional to join our team as a Director, Regulatory. This role will serve as the Regulatory Lead for our pivotal program leading to BLA. In this role, you will be responsible for developing and executing regulatory strategies to support the development and commercialization of our cell therapy products. You will work closely with cross-functional teams, regulatory agencies, and external partners to ensure compliance with regulatory requirements and successful product registration. If you are a passionate and experienced regulatory affairs professional with a strong knowledge of BLA requirements, we encourage you to apply for this position that will play a crucial role in advancing innovative cell therapies to benefit patients worldwide. Key Responsibilities: Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable. 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. Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly. Assess and communicate potential regulatory risks and propose mitigation plans. Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA). Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements. Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products. Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication. Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities Coordinate and prepare responses to requests for information from regulatory agencies Build and maintain positive relationships with regulatory authorities to facilitate successful regulatory approvals. Qualifications: Bachelor's degree in life sciences or related field required (advanced degree preferred). Minimum of 8 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred). Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required). Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions. Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions. Excellent communication, negotiation, and leadership skills 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, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://www.cabalettabio.com/join-our-crew 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, an employment agency, or a 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, and/or firm. #LI-REMOTE