Senior Regulatory Affairs Lead, Submissions & Strategy

OpenKrill; United States; Hybrid; USD 165,000 - 203,000; Full time

Job summary

Umoja Biopharma seeks a Senior Manager/Associate Director of Clinical Regulatory Affairs to drive global regulatory strategy for in vivo CAR T and cell therapy programs. This role focuses on submissions, health authority interactions, and cross-functional collaboration across the U.S., EU, and other markets.

Seattle-based hybrid work is available through on-site collaboration two days a week. The candidate will guide regulatory planning, contribute to briefing packages, and ensure compliance

Qualifications

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field.
• 6+ years regulatory affairs experience for Senior Manager; 8+ years for Associate Director.
• Strong regulatory strategy and operations knowledge across US, EU, and global markets.
• Excellent written and verbal communication; ability to prepare executive summaries.
• Strong project management, organizational, and prioritization skills.

Responsibilities

• Develop and implement global clinical regulatory strategies for assigned programs.
• Prepare, review, and submit regulatory documents (INDs, CTAs, annual reports, safety reports).
• Collaborate with cross-functional teams to ensure timely, high-quality deliverables.
• Prepare for meetings with FDA/EMA and other health authorities; develop briefing materials.
• Provide regulatory input into study designs, IC/IBs, safety reports, and trial documentation.

Skills

Regulatory affairs

IND submissions

FDA submissions

Cross-functional collaboration

Project management

Education

Bachelor’s degree in life sciences, regulatory affairs, or related field

Job description

Umoja Biopharma seeks a Senior Manager/Associate Director of Clinical Regulatory Affairs to drive global regulatory strategy for in vivo CAR T and cell therapy programs. This role focuses on submissions, health authority interactions, and cross-functional collaboration across the U.S., EU, and other markets.

Seattle-based hybrid work is available through on-site collaboration two days a week. The candidate will guide regulatory planning, contribute to briefing packages, and ensure compliance