Clinical Regulatory Lead for Cell & Gene Therapies

Umoja Biopharma; Seattle (WA); On-site; USD 160,000 - 203,000; Full time

Benefits offered by this job

401k match

Paid time off

Commuter benefits

Cell phone stipend

Job summary

Umoja Biopharma seeks a Senior Manager or Associate Director of Regulatory Affairs to drive clinical regulatory strategy and submissions for in vivo CAR-T and cell/gene therapy programs. This role involves global health authority interactions across the US, EU, and beyond, with collaboration across clinical, medical writing, pharmacovigilance, and CMC teams.

The candidate will plan FDA/EMA meetings, develop briefing materials, and ensure timely regulatory deliverables, while maintaining

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 6+ years of regulatory affairs experience for Senior Manager; 8+ years for Associate Director.
• Strong understanding of regulatory strategy and operations across U.S., EU, and global markets.
• Excellent written and verbal communication; able to prepare executive-level summaries.
• Strong project management and ability to manage multiple deliverables in a dynamic environment.

Responsibilities

• Develop and implement global clinical regulatory strategies for assigned programs.
• Prepare, review, and submit regulatory documents including INDs, CTAs, amendments, and annual reports.
• Collaborate with cross-functional teams to ensure high-quality regulatory deliverables.
• Plan for FDA/EMA meetings with briefing materials, questions, responses, and post-meeting docs.
• Provide regulatory input into study designs, documents, and safety reports.
• Monitor regulatory guidance and precedents relevant to oncology, immunotherapy, cell/gene therapy.
• Identify regulatory risks and mitigate in alignment with program objectives.
• Maintain submission plans, timelines, trackers, and lifecycle management docs.
• Contribute to development of internal regulatory processes and templates.
• Represent Regulatory Affairs on project teams and partner with colleagues.

Skills

Regulatory strategy

Regulatory operations

Communication

Project management

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job description

Umoja Biopharma seeks a Senior Manager or Associate Director of Regulatory Affairs to drive clinical regulatory strategy and submissions for in vivo CAR-T and cell/gene therapy programs. This role involves global health authority interactions across the US, EU, and beyond, with collaboration across clinical, medical writing, pharmacovigilance, and CMC teams.

The candidate will plan FDA/EMA meetings, develop briefing materials, and ensure timely regulatory deliverables, while maintaining