Umoja Biopharma · 16 hours ago
Senior Director, Clinical Regulatory Affairs
Seattle, WA
Contract
Onsite
Director/Executive
$253K/yr - $312K/yr
12+ years expUmoja Biopharma is an industry-leading biotech focused on transforming cancer treatment with an innovative immunotherapy platform. The Senior Director of Regulatory Affairs will lead regulatory strategies and oversee submissions for drug products, playing a critical role in the development of CAR-T therapy programs.
BiopharmaBiotechnology
Responsibilities
Independently provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs
Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints, to support program advancement
Develop registration strategies and plans (e.g., TPP development and assessment) to achieve regulatory approvals and desired product labeling
Lead global regulatory filings (IND/CTA/BLA/MAA submissions), setting strategy for submissions of product registration documents for health authorities worldwide
Primary point of contact with global regulatory agencies to support program advancement
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders (as relevant)
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
Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, 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
Provide organizational support and mentoring as company grows its product development pipeline
Qualification
Required
PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs
Experience in Oncology, Hematology, or related specialty strongly preferred
Successful track record of regulatory submissions and approvals
Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred; experience in in vivo gene delivery a plus
Strong knowledge of global 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
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