Director, CMC Regulatory

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development.

We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

The Director, CMC Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Umoja’s drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading CMC-specific HA meetings). This role will serve as a technical regulatory leader, providing expertise to support the development of our in vivo CAR-T therapy programs.

This key role is critical to ensuring that process development activities support the global regulatory strategy and eventual licensure. This position will partner with the global regulatory lead in development and execution of the overall global regulatory strategy. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. This individual also performs regulatory assessments of proposed manufacturing changes and provides guidance on regulatory expectations throughout development.

• Provide technical regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings.
• Lead technical modules and sections of global regulatory filings (IND/CTA/BLA/MAA submissions), working with global regulatory lead to set strategy for submissions of product registration documents for health authorities worldwide.
• Interact with regulatory agencies and represent Regulatory CMC at HA meetings, including preparing subject matter experts (SMEs).
• Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects.
• Coordinate, manage, and lead all CMC regulatory projects including management of budget, timelines, and submission planning.
• Manage and ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports.
• Independently manage and prioritize Phase 1 IND through late-stage projects.
• Identify, communicate, and propose resolutions to both routine and complex issues.
• Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
• Provide regulatory expertise to business development, investor relations, and partnership discussions as needed.
• Collaborate closely with the global regulatory lead, translational medicine, preclinical, clinical, and technical teams to align overall strategy with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. Provide interpretation of regulatory authority feedback, policies, guidelines, and directives.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.

• Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 10/12/15 years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry. Successful track record of regulatory submissions and approvals.
• Senior Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 12/15/15+ years of regulatory drug development…