Senior Director, Clinical Regulatory Affairs

Umoja Biopharma

Senior Director, Regulatory Affairs at Umoja Biopharma, leading regulatory strategy and execution for in vivo CAR-T therapy programs. Spearheading regulatory submissions and collaborating with cross-functional teams in oncology.

Posted 6/30/2026full-timeLouisville • Colorado, Washington • 🇺🇸 United StatesSenior💰 $253,000 - $312,500 per yearWebsite

About the role

Key responsibilities & impact

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.
Develop registration strategies and plans to achieve regulatory approvals.
Lead global regulatory filings (IND/CTA/BLA/MAA submissions).
Primary point of contact with global regulatory agencies.
Communicate the regulatory strategy, risks, mitigations, and overall plans to various stakeholders.
Identify, communicate, and propose resolutions to routine and complex issues.
Provide regulatory advice and guidance to project teams.
Collaborate closely with various teams to align overall strategy with scientific discoveries.
Stay current on emerging trends, competitors, and regulatory guidance in applicable areas.
Work with external program partners collaboratively and effectively.

Requirements

What you’ll need

PhD/MS/BS in a relevant scientific field required.
Minimum of 12/15/15+ years of relevant experience in regulatory affairs for Senior Director level.
Minimum of 15/18/18+ years of relevant experience in regulatory affairs for Executive Director level.
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.
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.

Benefits

Comp & perks

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.

ATS Keywords

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Hard Skills & Tools

Regulatory AffairsRegulatory Strategy DevelopmentRegulatory SubmissionsCell & Gene TherapyCAR-T TherapyTrial DesignEndpoints SelectionRegulatory ComplianceRisk MitigationEmerging Trends Analysis

Soft Skills

LeadershipCommunicationCross-Functional CollaborationProblem SolvingStakeholder Engagement