Director/Sr. Director of Regulatory Affairs

Philadelphia, PA

Cabaletta Bio is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Cabaletta’s therapeutic platform produces highly selective autologous Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The platform is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop the CAAR T technology to treat B cell-mediated autoimmune diseases. The Company’s lead therapeutic program is a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV), which is a rare skin disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team.  In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew

About the Position

Reporting initially to the VP of Compliance, the Director/Sr. Director of Regulatory Affairs will be responsible for driving the success and strategy of our regulatory affairs function. The role will be responsible for driving the Regulatory Affairs functional perspective as Cabaletta Bio makes important early decisions about nominating development candidates and building a diverse pipeline of future programs, as well as the continued development of current programs through the clinic.

Responsibilities include to:

  • Develop regulatory strategic plan and present recommendations to the Management Team, Board, and other advisory groups related to product development, study design, and acceleration opportunities.
  • Manage regulatory aspects of products and projects, including timelines and deliverables.
  • Act as the regulatory lead with experience in early clinical, pre-clinical, and end of Phase II, as well as CMC and CMC amendments.
  • Represent the regulatory function on related cross-functional program teams.
  • Plan, prepare, and review submissions to regulatory authorities (FDA, EMA, etc.) and other major national regulatory authorities to support the conduct of clinical trials and approval of marketing applications, including but not limited to IND, CTA, BLA, and MAA.
  • Provide innovative and proactive regulatory leadership to project teams that align with the development plan and corporate goals.
  • Ensure accuracy of regulatory documentation and compliance with major applicable regulatory authorities.
  • Prepare meeting requests, briefing documents, and lead teams for interface with regulatory authorities.
  • Prepare and draft responses to questions, requests for information from regulatory authorities.
  • Work with internal teams to foster collaboration and inspire teams for overall successful regulatory development.
  • May manage contract staff and vendors as needed to support Regulatory activities.

Required Qualifications

  • B.A./B.S. or higher degree in a scientific related discipline with 10 + years of regulatory affairs experience in the pharmaceutical or biotechnology space.
  • Experience guiding regulatory strategy for innovative, novel biologics; Specifically, cell therapy or gene therapy therapeutics.
  • Thorough knowledge of relevant FDA regulations that are relevant to cGMP manufacturing environments, RMAT designations and other venues to accelerate the development of novel therapeutics.
  • Demonstrated track record with regulatory agencies to create a path for novel biologics to advance into and through the clinic.
  • Experience engaging with regulatory agencies at different stages and successfully filing submissions.
  • Track record of experience within early pre-clinical development through IND/CTA.
  • Working knowledge of technical and clinical regulatory requirements
  • Ability to thrive when working in a fast-paced, innovative environment requiring flexibility, strategic agility, and creativity.
  • Thorough knowledge of the drug development process including CMC challenges and strategies supporting expedited drug development pathways for rare diseases
  • Extensive knowledge and understanding of global regulatory requirements and environment
  • Demonstrated strategic thinking and implementation in overall drug development

Preferred Qualifications

  • Global experience is highly preferred, including interactions with FDA, EMA, and national authorities in major EU countries.
  • Recent experience with pre- and post-approval (BLA/NDA/MAA) submissions and product lifecycle management.
  • Direct experience on early-stage cell or gene therapy products, leading regulatory strategy within a small biotech environment.

Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.

For more information, please visit https://www.cabalettabio.com/ or email careers@cabalettabio.com directly to submit an application. Please include your CV along with the title of the position you are applying for.

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.