Associate Director, CMC Regulatory
Lyell Immunopharma
August 21, 2026
Remote friendly (Seattle, WA)
United States
Corporate Functions
The incumbent will be responsible for providing CMC regulatory expertise through all stages of product lifecycle, supporting CMC Regulatory Affairs interactions with the FDA, representing CMC Regulatory on CMC and regulatory submission teams, creating timelines, and driving the submission plan for Quality Modules.
Key Role and Responsibilities:
- Provide phase-appropriate guidance on CMC regulatory requirements for cell therapy development.
- Lead CMC regulatory risk assessment; escalate critical issues to senior management and identify mitigation activities.
- Develop CMC content for original INDs, IND amendments, IMPDs for inclusion in CTAs and BLA/MAA.
- Prepare CMC updates for regulatory documents (e.g., Investigator Brochures, Annual Reports, premeeting packages).
- Coordinate/manage CMC regulatory projects; manage submission timelines and ensure timely reporting of CMC changes to health authorities.
- Maintain knowledge of the regulatory environment; identify CMC opportunity and risks across the development lifecycle.
- Partner to develop tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies.
Preferred Education:
- MSc or PhD in a scientific or related discipline.
Preferred Experience:
- 8+ years in CMC regulatory affairs.
- Experience leading CMC documentation and lifecycle management from IND to marketing applications in pharma/biotech.
- Cell therapy experience desirable.
- Global regulatory experience preferred.
- Minimum 2 years management experience preferred.
Knowledge/Skills:
- Knowledge of FDA, EMA, and ICH CMC regulations/guidelines for cell therapies.
- Track record preparing/reviewing/executing CMC regulatory documents for clinical and marketing applications.
- Strong oral/written communication; relationship-building with CMC and cross-functional teams.
- Ability to multi-task in a fast-paced start-up; detail-oriented with big-picture view.
- Familiarity with AI-assisted regulatory writing tools; appropriate use with human oversight and QC.
Compensation/Benefits:
- Salary range: $190,000 to $230,000 annually; opportunity for annual bonus; eligibility for Equity Incentive Plan.
Application Instructions:
- If you’re interested and think you could fit, please don’t hesitate to apply.
Key Role and Responsibilities:
- Provide phase-appropriate guidance on CMC regulatory requirements for cell therapy development.
- Lead CMC regulatory risk assessment; escalate critical issues to senior management and identify mitigation activities.
- Develop CMC content for original INDs, IND amendments, IMPDs for inclusion in CTAs and BLA/MAA.
- Prepare CMC updates for regulatory documents (e.g., Investigator Brochures, Annual Reports, premeeting packages).
- Coordinate/manage CMC regulatory projects; manage submission timelines and ensure timely reporting of CMC changes to health authorities.
- Maintain knowledge of the regulatory environment; identify CMC opportunity and risks across the development lifecycle.
- Partner to develop tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies.
Preferred Education:
- MSc or PhD in a scientific or related discipline.
Preferred Experience:
- 8+ years in CMC regulatory affairs.
- Experience leading CMC documentation and lifecycle management from IND to marketing applications in pharma/biotech.
- Cell therapy experience desirable.
- Global regulatory experience preferred.
- Minimum 2 years management experience preferred.
Knowledge/Skills:
- Knowledge of FDA, EMA, and ICH CMC regulations/guidelines for cell therapies.
- Track record preparing/reviewing/executing CMC regulatory documents for clinical and marketing applications.
- Strong oral/written communication; relationship-building with CMC and cross-functional teams.
- Ability to multi-task in a fast-paced start-up; detail-oriented with big-picture view.
- Familiarity with AI-assisted regulatory writing tools; appropriate use with human oversight and QC.
Compensation/Benefits:
- Salary range: $190,000 to $230,000 annually; opportunity for annual bonus; eligibility for Equity Incentive Plan.
Application Instructions:
- If you’re interested and think you could fit, please don’t hesitate to apply.