Senior Director, CMC Regulatory Affairs (Hybrid)

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

The 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 clinical trials, health authority interactions and product approvals.

The Regulatory Affairs, Senior Director CMC Regulatory Affairs will manage one direct report, the Regulatory Technical Writer, and will work together with the Technical Writer, the CMC team and Quality personnel to ensure thorough, high-quality submissions that are in compliance with US, EU, and ICH requirements. The CMC team is hybrid and are typically in the office 2-5 days a week; therefore, it is desirable that the person in this position will be available to be on site to meet with CMC personnel for key meetings and to facilitate communication and planning with the CMC team, as needed.

Responsibilities:

• Develop and implement CMC regulatory strategies to support the company's products and business objectives globally.
• 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.

Qualifications:

• Bachelor's degree in Biological Sciences; advanced degree in health sciences preferred, with at least 15 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.

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.