Director/Senior Director, Regulatory Affairs (Remote)

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ 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®

About the Position:

We are seeking an experienced and highly motivated professional to join our team as Director/Senior Director, Regulatory Affairs. 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 background in cell therapy, we encourage you to apply for this Director/Senior Director position to play a crucial role in advancing innovative cell therapies to benefit patients worldwide.

Responsibilities:

Manage the regulatory aspects from pre-IND through post-approval stages, of Cabaletta Bio products as assigned, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, 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.
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.
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.
Leadership and Mentorship (Director Level):
- If applying for the Director position, provide leadership and mentorship to regulatory affairs team members.
- Foster a culture of continuous learning and development within the regulatory affairs department.

Qualifications:

Bachelor's degree in life sciences or related field required (advanced degree preferred).
Minimum of 10 years of experience in regulatory affairs for biopharmaceuticals or cell therapy.
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience preferred).

Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions is preferred.

Regulatory experience with both early-stage development and marketed products preferred (for Director level).

Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions.

Excellent communication, negotiation, and leadership skills.
Prior leadership or management experience preferred (for Director level).
Strong team orientation and passion for continuous self-development.
Experience in the biotech industry or in a startup industrial setting is preferred.

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 based on 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.