Sr. Director, Clinical and Regulatory Writing

Role Summary

Senior Director, Clinical and Regulatory Writing. Role can be remote, hybrid or based in Philadelphia, PA. Oversees the development and delivery of high-quality regulatory and clinical documentation to support global regulatory submissions across the cell and gene therapy portfolio. Leads a small team and collaborates cross-functionally to ensure clear, compliant, and scientifically sound communication with regulatory agencies and stakeholders.

Responsibilities

• Lead 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, Prime, RMAT)
• Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
• Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
• Manage external consultants and contractors to support Cabaletta submissions, reviews, authoring, and gap analyses
• Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
• Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and business goals
• Drive process improvements and develop standard practices for efficient, compliant and high-quality 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 progressive 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 complex scientific data clearly and persuasively
• Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
• Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
• Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
• Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority
• Strong team orientation and passion for continuous self-development
• Experience in the biotech industry or startup industrial setting is preferred

Skills

• Regulatory writing
• Content planning and management
• Technical writing and editing
• Cross-functional collaboration
• Vendor management
• Regulatory submission preparation (IND, BLA, MAA, RMAT, etc.)
• Document management systems (e.g., Veeva Vault)
• Project management

Education

• Advanced degree in life sciences (M.D., PharmD preferred; MS/PhD considered with relevant experience)

Additional Requirements

• None beyond standard job qualifications listed above