Associate Director, Regulatory

Role Summary

Associate Director, Regulatory. Remote or based at our Philadelphia, PA headquarters. This role serves as the Regulatory Lead for our pivotal program leading to a BLA. 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.

Responsibilities

• Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, 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.

• Regulatory Submissions and Compliance: 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.

• Regulatory Interactions: 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.

Qualifications

• Bachelor's degree in life sciences or related field required (advanced degree preferred).
• Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred).
• Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required).
• Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions.
• Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions.
• Excellent communication, negotiation, and leadership skills
• Strong team orientation and passion for continuous self-development