Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases, including SLE/lupus nephritis and myositis and which uses a CD-19 binder that has an encouraging clinical tolerability profile. The second strategy is Cabaletta Bio’s proprietary CAART, or chimeric autoantibody receptor T cells, strategy, which is designed to cause antigen-specific B cell depletion of well-defined, disease-causing B cells. Our lead product candidate developed using the CAART strategy is being evaluated in a clinical trial for patients with mucosal pemphigus vulgaris (mPV) and our second product candidate is expected to initiate a clinical trial later this year in muscle-specific tyrosine kinase (MuSK) myasthenia gravis. Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and 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

The Director/Senior Director CMC Regulatory Affairs is responsible for leading and managing CMC regulatory affairs activities for the company and interfaces with the project teams to manage regulatory CMC aspects of projects related to support of clinical trials, health authority interactions and product approvals.

The Regulatory Affairs Director/Senior Director CMC Regulatory Affairs works with the CMC team and Quality personnel to ensure compliance of submissions and programs with US, EU, and ICH requirements.

Responsibilities:

Develop and implement CMC regulatory strategies to support the company's products and business objectives.
Provide CMC regulatory guidance to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
Preparation of CMC Module 3 and IMPD dossiers including CMC amendments to INDs/CTAs as required.
Participate in CMC change control to ensure released products are manufactured in agreement with established regulatory submissions and regulatory guidance.
Participate in process development and characterization risk assessment activities including developing a QTPP and planning for process validation to implement a quality by design approach.
Manage BLA CMC preparation and planning activities for marketed product readiness.
Develop CMC strategy for health authority interactions including preparation of meeting requests and meeting dossiers.
Assist CMC teams in the identification, evaluation, and escalation of project regulatory risks throughout project lifecycles and help devise appropriate mitigation strategies.
Build and maintain strong relationships with key stakeholders, including regulatory agencies, industry associations, and advocacy groups.
Ensure that the company's quality systems comply with all relevant regulations.

Qualifications:

Bachelor's degree in Biological Sciences; advanced degree in health sciences preferred, with at least 6 years of experience in the biotech/pharmaceutical industry.
Knowledge of GXPs and key requirements for CMC documentation for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics.
Experience in cell and gene therapy CMC, late-stage development and commercial launch experience is desirable.
Experience in reviewing and writing CMC regulatory submission documents for global regulatory filings such as IMPD, CTAs, and MAAs and related health authority interactions is preferred.
Strong analytical and problem-solving skills.
Ability to support multiple projects and to prioritize work independently in a fast-paced, deadline-driven environment.
Strong leadership skills and the ability to manage and motivate a team.
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory issues to a variety of audiences.
Strong team orientation and passion for continuous self-development.
Experience in industry or in ap 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 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.