Umoja Biopharma · 15 hours ago
Director, CMC Regulatory
Seattle, WA
Contract
Onsite
Director/Executive
$206K/yr - $255K/yr
10+ years expUmoja Biopharma is an industry-leading biotech focused on transforming cancer treatment with innovative immunotherapy solutions. The Director, CMC Regulatory Affairs will lead the development and execution of regulatory strategies for drug submissions, ensuring compliance and providing technical leadership in the development of CAR-T therapy programs.
BiopharmaBiotechnology
Responsibilities
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
Qualification
Required
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
Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus
Strong knowledge of global CMC regulatory requirements for early- and late-stage development of gene and cell therapies
Proven ability to interact with regulatory authorities
Excellent communication, leadership, and cross-functional collaboration skills
Passion for innovation and commitment to advancing transformative therapies for patients
Ability to travel (~20%) for team meetings and/or regulatory interactions as required
Ability to sit for prolonged periods of time
Benefits
Competitive Medical, Dental, and Vision plans
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
Company
Umoja Biopharma
Umoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$363MKey Investors
DCVC Bio
2025-01-14Series C· $100M
2021-06-15Series B· $210M
2020-11-18Series A· $53M
Leadership Team
Ryan Crisman
Co-Founder and Chief Technology Officer
Recent News
BioWorld Financial Watch
2025-12-29
Company data provided by crunchbase