Director, Regulatory Affairs

3 weeks ago

Seattle, United States BrainChild Bio Full time

BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs. This role will serve as BrainChild Bio’s primary regulatory representative, responsible for guiding regulatory activities across preclinical, clinical, and manufacturing stages, while partnering closely with internal teams and external partners.The Director will work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. Responsibilities include developing regulatory strategies that support innovative CAR T development, preparing for and participating in FDA and ex-US health authority interactions, and ensuring documentation and filings are complete, accurate, and timely.The ideal candidate brings substantial experience in Regulatory Affairs within a clinical-stage biotech, strong working knowledge of FDA regulations for cell and gene therapy products, and the ability to operate both strategically and hands-on. We’re seeking a collaborative, detail-oriented leader who thrives in a fast-moving environment and is motivated by bringing transformative therapies to patients.ResponsibilitiesLead and execute regulatory strategies to support development of CAR T programs.Prepare, review, and submit INDs, amendments, and regulatory correspondence to FDA and other global health authorities.Serve as primary regulatory contact with health authorities, including FDA, EMA and other global agencies, representing BrainChild Bio in meetings and discussions.Collaborate cross-functionally with Clinical, CMC, Quality, and Patient Operations to ensure regulatory compliance and alignment with program objectivesIdentify risks and opportunities, providing strategic recommendations to accelerate development timelines.Advise on regulatory implications of protocols, manufacturing processes, and patient logistics.Manage regulatory timelines, submissions, and deliverables across multiple programs.Stay informed of emerging regulations, guidance documents, and industry trends specific to cell and gene therapy.Qualifications10+ years of regulatory affairs experience, including significant experience in cell and gene therapy, or advanced biologics.Strong working knowledge of FDA regulations and guidance for CAR T and other cell therapy products, as well as global regulatory frameworks.Demonstrated ability to develop strategic regulatory plans and execute them in a fast-paced clinical-stage biotech environment.Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution.Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders.Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies.$195,000 - $210,000 a year #J-18808-Ljbffr

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