Umoja Biopharma

Medical Director

• Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs
• Develop and execute global regulatory strategies supporting indication selection, trial design, endpoints, and program advancement
• Develop registration strategies and plans, including TPP development and assessment, to achieve regulatory approvals and desired product labeling
• Lead global regulatory filings, including IND, CTA, BLA, and MAA submissions
• Serve as the primary point of contact with global regulatory agencies
• Communicate regulatory strategy, risks, mitigations, and plans to Regulatory Affairs, program teams, senior management, and external stakeholders
• Identify, communicate, and propose resolutions to routine and complex issues
• Provide regulatory advice and guidance to project teams based on scientific data, regulatory guidance, and precedent
• Collaborate with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams
• Monitor emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas
• Conduct regulatory research and interpret regulatory authority feedback, policies, guidelines, and directives
• Work with external program partners to deliver contractual obligations and corporate priorities
• Provide organizational support and mentoring as the company grows its product development pipeline

Senior Director, Clinical Regulatory Affairs

Compliance

• Support the development and implementation of global clinical regulatory strategies for assigned programs, including early- and mid-stage clinical development plans
• Contribute to the preparation, review, and submission of regulatory documents, including INDs, CTAs, protocol amendments, annual reports, briefing packages, health authority responses, and components of marketing applications as applicable
• Partner with clinical development, clinical operations, medical writing, pharmacovigilance, CMC, nonclinical, program management, and external regulatory consultants to ensure high-quality, timely regulatory deliverables
• Assist in planning and preparing for FDA, EMA, national competent authority, and other global health authority meetings, including briefing materials, questions, responses, meeting strategy, and post-meeting documentation
• Provide regulatory input into clinical study designs, protocols, investigator brochures, informed consent documents, safety reports, and other clinical trial documentation
• Monitor regulatory requirements, guidance documents, precedents, and competitive intelligence relevant to oncology, immunotherapy, cell therapy, gene therapy, biologics, and rare or serious disease development
• Support cross-functional teams by identifying regulatory risks, proposing mitigation strategies, and helping ensure alignment with program objectives and evolving health authority expectations
• Help maintain regulatory submission plans, timelines, trackers, and documentation to support inspection readiness and lifecycle management
• Contribute to the development of internal regulatory processes, best practices, templates, and standards as the regulatory function grows
• Represent Regulatory Affairs on assigned project teams and act as a trusted partner to cross-functional colleagues

Senior Director, Clinical Regulatory Affairs

Senior Manager, Clinical Regulatory Affairs