Associate Director, CMC Regulatory — Cell Therapy | Equity

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

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma in Seattle is seeking an experienced CMC Regulatory Affairs professional to provide phase-appropriate guidance, manage submission timelines, and coordinate regulatory strategies for cell therapy development.

With 8+ years in regulatory affairs, you will lead CMC documents from IND to marketing, collaborate with FDA/EMA, and mentor junior staff in a fast-paced biotech start-up environment.

Qualifications

• Knowledge of FDA, EMA and ICH CMC regulations and guidelines for cell therapies.
• Proven track record in preparing, reviewing and executing CMC regulatory documents to support clinical studies and marketing applications.
• Experience leading CMC regulatory documentation and lifecycle management from IND to marketing applications.

Responsibilities

• Provide phase-appropriate guidance related to CMC regulatory requirements and expectations for cell therapy development.
• Lead CMC regulatory risk assessment and escalate critical issues to senior management.
• Collaborate with CMC colleagues to develop content for original INDs, IND amendments, IMPDs for CTA and BLA/MAA submissions.
• Prepare CMC updates for regulatory documents including Investigator Brochures and Annual Reports.

Skills

CMC regulatory affairs

Regulatory submission planning

Cross-functional collaboration

Regulatory risk assessment

Regulatory writing familiarity with AI

Education

MSc/PhD in science

Job description

Lyell Immunopharma in Seattle is seeking an experienced CMC Regulatory Affairs professional to provide phase-appropriate guidance, manage submission timelines, and coordinate regulatory strategies for cell therapy development.

With 8+ years in regulatory affairs, you will lead CMC documents from IND to marketing, collaborate with FDA/EMA, and mentor junior staff in a fast-paced biotech start-up environment.