Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.

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Senior Director, CMC Regulatory Affairs

Philadelphia, PA

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 Include

  • 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.

Required 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.

How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.