Join Our Crew

Responsibilities Include

• Manage the regulatory aspects from pre-IND through post-approval stages, of Cabaletta Bio products as assigned, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, 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.
• 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.
• 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.
• Provide leadership and mentorship to regulatory affairs team members.
• Foster a culture of continuous learning and development within the regulatory affairs department.

Required Qualifications

• Bachelor's degree in life sciences or related field required (advanced degree preferred).
• Minimum of 7-10 years of experience in regulatory affairs for biopharmaceuticals or cell therapy.
• Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience preferred).
• Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions is preferred.
• Regulatory experience with both early-stage development and marketed products preferred (for Director level).
• Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions.
• Excellent communication, negotiation, and leadership skills.
• Prior leadership or management experience preferred (for Director level).
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in a startup industrial setting is preferred.

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