Sr. Director, Clinical and Regulatory Writing

Senior Director, Clinical and Regulatory Writing Philadelphia, PA reputed company (reputed company: CABA) is a clinical-stage biotechnology company reputed company on developing and launching the first reputed company targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps reputed company, treatments for a broad reputed company of autoimmune diseases. The reputed company reputed company (Chimeric Antigen Receptor T cells for Autoimmunity) reputed company is prioritizing the development of rese-cel, a 4-1BB-containing fully reputed company CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. reputed company's reputed company and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on reputed company. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is reputed company on the reputed company of reputed company. To nurture this, we reputed company an reputed company commitment to reputed company-being and reputed company reputed company of reputed company employee who joins reputed company. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We're proud to be a Great reputed company to Work-Certified company! #GPTWcertified reputed company out what our employees say makes working here so great: Working at reputed company | Great reputed company to Work Position reputed company: This role can be remote, hybrid or based in our Philadelphia, PA reputed company. The Senior Director, Clinical and Regulatory Writing will serve as a strategic leader reputed company the Clinical, Medical and Regulatory organization, overseeing the development and delivery of high-reputed company regulatory and clinical documentation to support global regulatory submissions across the cell and gene therapy portfolio. This role partners cross-functionally with Regulatory, reputed company, Clinical, Nonclinical, CMC, and external collaborators to ensure reputed company, compliant, and scientifically reputed company communication with regulatory agencies and other stakeholders. The Senior Director will reputed company a small team and be a key contributor to global regulatory reputed company, content planning and drafting for regulatory designations, clinical updates and clinical modules of the BLA/MAA. Responsibilities:

• reputed company the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, reputed company, RMAT)
• reputed company cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
• Translate reputed company technical data from clinical and biostatistics teams into scientifically accurate, submission-reputed company documentation
• Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
• Mentor, train, and manage reputed company of medical/regulatory/technical writers or cross-functional contributors in document development
• reputed company and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
• Drive process improvements and reputed company reputed company practices for efficient, compliant and high-reputed company document delivery
• Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

Qualifications:

• Advanced degree in life sciences (M.D., or PharmD preferred); MS, PhD with significant clinical pharmacology writing experience will be considered
• 12+ years of reputed company experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
• Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
• Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
• Exceptional writing, editing, and analytical skills with the ability to convey reputed company scientific data reputed company and persuasively
• Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
• Proficiency in reputed company Office Suite, document management systems (e.g., reputed company Vault), and electronic publishing tools
• Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
• reputed company reputed company with the ability to influence and guide stakeholders across disciplines and reputed company of seniority
• Strong team orientation and passion for reputed company self-development
• Experience in the biotech industry or in a startup industrial setting is preferred

Our reputed company - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging reputed company of an operatic aria, designed to showcase the skills of the reputed company singer. Analogously, reputed company strives to reputed company rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the reputed company of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://www.cabalettabio.com/join-our-reputed company Our most important asset is our people, and we offer competitive benefits, PTO, and stock reputed company plans. reputed company is an equal opportunity employer. We do not discriminate on the reputed company of race, reputed company, gender, gender identity, sexual orientation, age, religion, national or ethnic reputed company, disability, protected veteran status or any other reputed company protected by applicable law. reputed company. does not accept unsolicited resumes from recruiters, employment agencies, or reputed company firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any reputed company of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a reputed company firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE Apply tot his job Apply To this Job