[Remote] Senior Manager, Clinical Regulatory Affairs

Note: The job is a remote job and is open to candidates in USA. Umoja Biopharma is hiring a Senior Manager/Associate Director, Clinical Regulatory Affairs to support and drive clinical regulatory strategy and execution for its in vivo CAR T and cell and gene therapy programs. The role contributes to global regulatory submissions and health authority interactions across the United States, European Union, and other markets.

Responsibilities

• 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 development of 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

Skills

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related field required
• Senior Manager: 6+ years of relevant regulatory affairs experience
• Associate Director: 8+ years of demonstrated experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs
• Strong understanding of clinical regulatory strategy and regulatory operations across U.S., EU, and global markets
• Excellent written and verbal communication skills, with the ability to prepare clear regulatory documents and executive-level summaries
• Strong project management, organizational, and prioritization skills with the ability to manage multiple deliverables in a dynamic environment
• Collaborative working style with the ability to influence without authority and build productive cross-functional relationships
• Sound judgment, attention to detail, and ability to identify regulatory issues early and propose practical solutions
• Comfort operating in a growing organization where processes are evolving and individuals are expected to be hands-on, adaptable, and accountable
• Commitment to patient-focused drug development and high standards of quality, compliance, and scientific integrity
• Advanced degree preferred
• Hands-on experience with FDA submissions and interactions, including INDs, protocol amendments, annual reports, safety reports, briefing packages, and responses to information requests
• Experience supporting EU and/or broader global clinical trial applications and health authority interactions, including CTAs, substantial amendments, and engagement with EMA or national competent authorities
• Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements, GCP, and global clinical development expectations
• Experience in biotechnology, pharmaceutical, or cell and gene therapy environments preferred
• Demonstrated ability to interpret regulatory guidance, assess implications for development programs, and communicate recommendations clearly to cross-functional teams

Benefits

• Competitive Medical, Dental, and Vision plans
• Access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral
• Generous Paid Time Off policy
• Employee commuter benefits
• Cell phone stipend
• Remote work in the United States
• If based in Seattle, WA, work on site 2 days/ week

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