Senior CMC Regulatory Lead - Cell Therapy

Lyell-Immunopharma,-Inc.; Seattle (WA); On-site; USD 190,000 - 230,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma, Inc. is seeking an experienced CMC Regulatory Affairs Leader to guide cell therapy regulatory strategy and drive timely, compliant submissions with U.S. FDA oversight.

You will develop CMC content for INDs, amendments, IMPDs, CTAs and BLA/MAA, coordinate submission timelines, mentor teams, and ensure ongoing regulatory compliance across the product lifecycle in a fast‑growing biotech.

Qualifications

• Minimum 8 years in CMC regulatory affairs
• Leading CMC documentation and lifecycle management from IND to marketing applications
• Cell therapy experience desirable
• Global regulatory experience preferred
• 2+ years of management experience preferred

Responsibilities

• Provide phase-appropriate guidance related to CMC regulatory requirements and expectations for cell therapy development
• Ensure timely escalation of critical issues to senior management by leading CMC regulatory risk assessment, identifying key CMC regulatory issues and mitigation activities needed throughout product life cycle
• Collaborate with CMC colleagues to develop CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications (CTA) and BLA/MAA
• Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and premeeting meeting packages for Regulatory Authority meetings
• Coordinate, manage CMC regulatory projects including management of submission timelines, ensuring that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
• Maintain knowledge of the regulatory environment, regulations, and procedures. Identify CMC regulatory opportunity and risks across development lifecycle
• Partner with key stakeholders in developing tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies

Skills

CMC regulatory

Regulatory risk assessment

Regulatory submissions

Cross-functional collaboration

FDA/EMA knowledge

Regulatory writing

Education

MSc/PhD in scientific discipline

Tools

Regulatory writing tools

Project management software

Job description

Lyell Immunopharma, Inc. is seeking an experienced CMC Regulatory Affairs Leader to guide cell therapy regulatory strategy and drive timely, compliant submissions with U.S. FDA oversight.

You will develop CMC content for INDs, amendments, IMPDs, CTAs and BLA/MAA, coordinate submission timelines, mentor teams, and ensure ongoing regulatory compliance across the product lifecycle in a fast‑growing biotech.