Apply on Employer Site

Cabaletta Bio · 6 days ago

Associate Director, Regulatory

All, MO

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

Cabaletta Bio is a clinical-stage biotechnology company focused on developing targeted cell therapies for autoimmune diseases. They are seeking an experienced Associate Director, Regulatory to lead the regulatory strategy for their pivotal program leading to BLA, ensuring compliance and successful product registration.

BiotechnologyHealth CareMedicalRoboticsTherapeutics

Responsibilities

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

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

Qualification

Regulatory AffairsBLA ExperienceRegulatory SubmissionsDrug Development ProcessGXP KnowledgeTeam OrientationSelf-DevelopmentCommunication SkillsNegotiation SkillsLeadership Skills

Required

Bachelor's degree in life sciences or related field required

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